Trial Outcomes & Findings for Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique (NCT NCT02256891)

Results Overview

The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

Baseline

Results posted on

2017-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Double Row Double Row Double Row	Double Row With PRFM Double Row with PRFM PRFM Double Row
Overall Study STARTED	55	42
Overall Study COMPLETED	43	29
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Double Row Double Row Double Row	Double Row With PRFM Double Row with PRFM PRFM Double Row
Overall Study Death	0	2
Overall Study Lost to Follow-up	0	3
Overall Study Physician Decision	7	3
Overall Study Screen Fail	5	4
Overall Study Equipment Malfunction	0	1

Baseline Characteristics

Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Row Only n=55 Participants Double Row	Double Row With PRFM n=42 Participants PRFM	Total n=97 Participants Total of all reporting groups
Age, Continuous	53.00 years n=5 Participants	58.64 years n=7 Participants	56.15 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	42 participants n=7 Participants	97 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Outcome measures

Outcome measures
Measure	Double Row n=44 Participants Double Row	Double Row With PRFM n=32 Participants PRFM
Return to Function	1257.45 units on a scale Standard Deviation 396.07	1106.31 units on a scale Standard Deviation 393.78

PRIMARY outcome

Timeframe: 6 months

The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Outcome measures

Outcome measures
Measure	Double Row n=40 Participants Double Row	Double Row With PRFM n=31 Participants PRFM
Return to Function	371.38 units on a scale Standard Deviation 312.18	297.13 units on a scale Standard Deviation 221.21

PRIMARY outcome

Timeframe: 24 months

Population: The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.

Western Ontario Rotator Cuff Index

Outcome measures

Outcome measures
Measure	Double Row n=41 Participants Double Row	Double Row With PRFM n=28 Participants PRFM
Return to Function	174.8 units on a scale Standard Deviation 254.41	103.11 units on a scale Standard Deviation 144.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=44 Participants Double Row	Double Row With PRFM n=32 Participants PRFM
Spraspinatus Strength Measurements	45.4 percentage of uninvolved Standard Deviation 34.2	51.8 percentage of uninvolved Standard Deviation 32.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes.

Outcome measures

Outcome measures
Measure	Double Row n=42 Participants Double Row	Double Row With PRFM n=27 Participants PRFM
MRI	3.21 scores on a scale Standard Deviation 1.07	2.74 scores on a scale Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=40 Participants Double Row	Double Row With PRFM n=27 Participants PRFM
Supraspinatus Strength Measurements	73.0 percentage of uninvolved Standard Deviation 29.0	81.0 percentage of uninvolved Standard Deviation 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=40 Participants Double Row	Double Row With PRFM n=28 Participants PRFM
Supraspinatus Strength Measurements	101.0 percentage of uninvolved Standard Deviation 53.0	96.0 percentage of uninvolved Standard Deviation 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=44 Participants Double Row	Double Row With PRFM n=32 Participants PRFM
Infraspinatus Strength Measurements	73.6 percentage of uninvolved Standard Deviation 67.4	73.7 percentage of uninvolved Standard Deviation 24.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=40 Participants Double Row	Double Row With PRFM n=27 Participants PRFM
Infraspinatus Strength Measurements	90.0 percentage of uninvolved Standard Deviation 33.0	96.0 percentage of uninvolved Standard Deviation 22.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.

Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.

Outcome measures

Outcome measures
Measure	Double Row n=40 Participants Double Row	Double Row With PRFM n=28 Participants PRFM
Infraspinatus Strength Measurements	102.0 percentage of uninvolved Standard Deviation 23.0	104.0 percentage of uninvolved Standard Deviation 13.0

Adverse Events

Double Row

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Double Row With PRFM

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Double Row n=55 participants at risk Double Row Double Row	Double Row With PRFM n=42 participants at risk Double Row with PRFM PRFM Double Row
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncological	0.00% 0/55 • 24 month 24 month visit	2.4% 1/42 • Number of events 1 • 24 month 24 month visit
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	7.3% 4/55 • Number of events 4 • 24 month 24 month visit	2.4% 1/42 • Number of events 2 • 24 month 24 month visit
Musculoskeletal and connective tissue disorders Musculoskeletal	3.6% 2/55 • Number of events 3 • 24 month 24 month visit	2.4% 1/42 • Number of events 1 • 24 month 24 month visit
Eye disorders Optomological	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit
Ear and labyrinth disorders ENT	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit
Renal and urinary disorders Urinary	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit
Skin and subcutaneous tissue disorders Dermatological	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit
Endocrine disorders Endocrine	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit
Nervous system disorders Neurological	1.8% 1/55 • Number of events 1 • 24 month 24 month visit	0.00% 0/42 • 24 month 24 month visit

Additional Information

Michael Walsh

Health Partners

Phone: (952) 831-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place