Trial Outcomes & Findings for Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears (NCT NCT02420353)

Results Overview

Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

at 26 wks post-op

Results posted on

2020-01-06

Participant Flow

Recruitment completed at the University of Michigan Sports Medicine Clinic

Participant milestones

Participant milestones
Measure	Somatropin Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Overall Study STARTED	10	10
Overall Study Allocation to Intervention	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Somatropin Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	9 Participants n=9 Participants	19 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants
Sex: Female, Male Female	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants
Sex: Female, Male Male	10 Participants n=10 Participants	9 Participants n=9 Participants	19 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Isokinetic Knee Strength (Nm) Absolute Isokinetic Flexion 60 dg/s Surgical	74.7 Newton Meters STANDARD_DEVIATION 27.9 • n=10 Participants	77.5 Newton Meters STANDARD_DEVIATION 11.4 • n=9 Participants	76.0 Newton Meters STANDARD_DEVIATION 21.2 • n=19 Participants
Isokinetic Knee Strength (Nm) Absolute Isokinetic Extension 60 dg/s Surgical	127.9 Newton Meters STANDARD_DEVIATION 46.7 • n=10 Participants	124.7 Newton Meters STANDARD_DEVIATION 43.1 • n=9 Participants	126.3 Newton Meters STANDARD_DEVIATION 43.8 • n=19 Participants

PRIMARY outcome

Timeframe: at 26 wks post-op

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op	0.881 Nm Interval 0.701 to 1.061	0.681 Nm Interval 0.532 to 0.83

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isokinetic Extension (Nm) at Pre-op (Baseline)	0.746 Nm Interval 0.627 to 0.865	0.816 Nm Interval 0.651 to 0.981

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)	0.738 Nm Interval 0.643 to 0.833	0.92 Nm Interval 0.772 to 1.068

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.

Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op	1.068 Nm Interval 0.955 to 1.181	1.028 Nm Interval 0.841 to 1.215

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isometric Extension (Nm) at Pre-op (Baseline)	0.761 Nm Interval 0.646 to 0.876	0.778 Nm Interval 0.676 to 0.88

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isometric Extension (Nm) at 26 Weeks Post-op	0.718 Nm Interval 0.64 to 0.796	0.633 Nm Interval 0.513 to 0.753

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isometric Flexion (Nm) at Pre-op (Baseline)	0.771 Nm Interval 0.641 to 0.901	0.867 Nm Interval 0.732 to 1.002

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normative Isometric Flexion (Nm) at 26 Weeks Post-op	1.017 Nm Interval 0.766 to 1.268	0.954 Nm Interval 0.847 to 1.061

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isokinetic Extension (Nm) at Pre-op (Baseline)	127.9 Nm Interval 100.8 to 155.0	124.7 Nm Interval 98.0 to 151.4

SECONDARY outcome

Timeframe: at 26 wk post-op

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isokinetic Extension (Nm) at 26 wk Post-op	140.1 Nm Interval 111.7 to 168.5	105.6 Nm Interval 79.7 to 131.5

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline)	74.7 Nm Interval 58.5 to 90.9	77.5 Nm Interval 70.4 to 84.6

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op	103.9 Nm Interval 85.3 to 122.5	86.2 Nm Interval 77.9 to 95.4

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isometric Extension (Nm) at Pre-op (Baseline)	183.1 Nm Interval 147.4 to 218.8	172.1 Nm Interval 139.0 to 205.2

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isometric Extension (Nm) at 26 Weeks Post-op	172.4 Nm Interval 145.8 to 199.0	140.3 Nm Interval 107.4 to 173.2

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).

Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isometric Flexion (Nm) at Pre-op (Baseline)	69.2 Nm Interval 55.7 to 82.7	77.2 Nm Interval 63.6 to 90.8

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.

Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Isometric Flexion (Nm) at 26 Weeks Post-op	84.6 Nm Interval 74.0 to 95.2	88.1 Nm Interval 72.4 to 103.8

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.

The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline)	46.5 T-score Interval 40.9 to 52.1	45.1 T-score Interval 40.6 to 49.6

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.

The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op	52.9 T-score Interval 51.2 to 54.6	50.2 T-score Interval 47.6 to 52.8

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.

The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline)	54.6 T-score Interval 48.8 to 60.4	55.6 T-score Interval 51.7 to 59.5

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.

The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op	56.7 T-score Interval 52.9 to 60.5	59.3 T-score Interval 56.3 to 62.3

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.

The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
International Knee Document Committee (IKDC) at Pre-op (Baseline)	54.6 score on a scale Interval 48.8 to 60.4	55.6 score on a scale Interval 51.7 to 59.5

SECONDARY outcome

Timeframe: up to 26 wk post-op

Population: A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.

The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
International Knee Documentation Committee (IKDC) up to 26 wk Post-op	65 units on a scale Interval 60.6 to 69.4	67 units on a scale Interval 58.7 to 75.3

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op	98 score on a scale Interval 96.0 to 100.0	98.0 score on a scale Interval 95.6 to 100.4

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline)	88 score on a scale Interval 82.8 to 93.2	91 score on a scale Interval 84.1 to 97.9

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op	91 score on a scale Interval 88.1 to 93.9	92 score on a scale Interval 87.2 to 96.8

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline)	74 score on a scale Interval 69.2 to 78.8	83 score on a scale Interval 75.0 to 91.0

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op	53 score on a scale Interval 42.8 to 63.2	63 score on a scale Interval 53.1 to 72.9

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline)	33 score on a scale Interval 23.1 to 42.9	47 score on a scale Interval 31.1 to 62.9

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op	67.5 score on a scale Interval 57.3 to 77.7	72.2 score on a scale Interval 56.2 to 88.2

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline)	46.5 score on a scale Interval 30.7 to 62.3	55.6 score on a scale Interval 41.1 to 70.1

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op	60 score on a scale Interval 52.9 to 67.1	68 score on a scale Interval 62.8 to 73.2

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.

KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline)	53 score on a scale Interval 45.7 to 60.3	64 score on a scale Interval 59.9 to 68.1

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Quadriceps Volume (L) at Pre-op (Baseline)	2.48 Liters Interval 2.16 to 2.8	2.12 Liters Interval 1.97 to 2.27

SECONDARY outcome

Timeframe: at 26 week post-op

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Quadricep Volume (L) at 26 Week Post-op	2.27 Liters Interval 2.02 to 2.52	2.12 Liters Interval 1.88 to 2.36

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Hamstring Volume (L) at Pre-op (Baseline)	1 Liters Interval 0.93 to 1.07	0.88 Liters Interval 0.85 to 0.91

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Absolute Hamstring Volume (L) at 26 Weeks Post-op	0.98 Liters Interval 0.89 to 1.07	0.88 Liters Interval 0.84 to 0.92

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normalized Quadriceps Volume (L) at Pre-op (Baseline)	1 Liters Interval 0.87 to 1.13	0.85 Liters Interval 0.79 to 0.91

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normalized Quadriceps Volume (L) at 26 Weeks Post-op	0.91 Liters Interval 0.81 to 1.01	0.85 Liters Interval 0.75 to 0.95

SECONDARY outcome

Timeframe: at pre-op (baseline)

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normalized Hamstring Volume (L) at Pre-op (Baseline)	1.06 Liters Interval 0.99 to 1.13	0.93 Liters Interval 0.89 to 0.97

SECONDARY outcome

Timeframe: at 26 weeks post-op

Population: Scans were performed on a total of 19 participant at three time points throughout the study.

Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Normalized Hamstring Volume (L) at 26 Weeks Post-op	1.03 Liters Interval 0.94 to 1.12	0.93 Liters Interval 0.88 to 0.98

SECONDARY outcome

Timeframe: Area under the curve between -1 and 5 weeks post-op

Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.

IGF1 was measured from serum using an IMMULITE 2000 system (Siemens).

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op	22478 ng*days/mL Interval 19505.0 to 25451.0	10626 ng*days/mL Interval 8749.0 to 12503.0

SECONDARY outcome

Timeframe: Area under the curve between -1 and 5 weeks post-op

Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.

Myostatin was measured from plasma using ELISAs (R\&D Systems, Minneapolis, MN) following manufacturer recommendations.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Myostatin at -1 and 5 Weeks Post-op	190.7 ng*days/mL Interval 170.3 to 211.1	193.6 ng*days/mL Interval 175.3 to 211.9

SECONDARY outcome

Timeframe: Area under the curve between -1 and 5 weeks post-op

Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.

Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R\&D Systems, Minneapolis, MN) following manufacturer recommendations.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
MMP3 at -1 and 5 Weeks Post-op	1188 ng*days/mL Interval 924.0 to 1452.0	766 ng*days/mL Interval 631.0 to 901.0

SECONDARY outcome

Timeframe: Area under the curve between -1 and 5 weeks post-op

Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.

Hyaluronic acid was measured from plasma using ELISAs (R\&D Systems, Minneapolis, MN) following manufacturer recommendations.

Outcome measures

Outcome measures
Measure	Somatropin n=10 Participants Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 Participants A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Hyaluronic Acid at -1 and 5 Weeks Post-op	190.7 ng*days/mL Interval 170.3 to 211.1	193.6 ng*days/mL Interval 175.3 to 211.9

Adverse Events

Somatropin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Christopher Mendias

Hopsital For Special Surgery and University of Michigan

Phone: 212-249-2373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Somatropin n=10 participants at risk Somatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.	Placebo n=9 participants at risk A placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
General disorders Back pain	50.0% 5/10 • Number of events 5 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	55.6% 5/9 • Number of events 5 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Fatigue	40.0% 4/10 • Number of events 4 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	44.4% 4/9 • Number of events 4 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Joint pain (other than surgical knee)	30.0% 3/10 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	22.2% 2/9 • Number of events 2 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Headache	30.0% 3/10 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 3/9 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Increased sweating	30.0% 3/10 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	22.2% 2/9 • Number of events 2 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Tingling sensation/numbness	20.0% 2/10 • Number of events 2 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.1% 1/9 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Elevated alanine aminotransferase	20.0% 2/10 • Number of events 2 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 3/9 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Elevated aspirate aminotransferase	20.0% 2/10 • Number of events 2 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 3/9 • Number of events 3 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Temperature sensation fluctuations	10.0% 1/10 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/9 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/9 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Reduced appetite	10.0% 1/10 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/9 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Elevated blood glucose	0.00% 0/10 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.1% 1/9 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/9 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Injection site bruising	0.00% 0/10 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	11.1% 1/9 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Muscle spasms/cramps	10.0% 1/10 • Number of events 1 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/9 • 1-3 weeks pre-op to 25 weeks post-op Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.