Trial Outcomes & Findings for Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results? (NCT NCT00492973)

NCT ID: NCT00492973

Last Updated: 2013-12-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: days after surgery
• Results posted on: 2013-12-19

Participant Flow

Between 5/1/2006 and 5/1/2008, a total of 101 patients were recruited to participate in the study during a regularly-scheduled office visit at an orthopedic clinic.

Of the 101 patients that were consented, 11 patients opted to cancel surgery, 11 patients asked to be removed from the study prior to surgery, and 3 patients were excluded as they were found to have existing allergies to study medications. The remaining sample of 76 patients were randomly assigned to one of the two study groups.

Participant milestones

Measure	Control Group Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Overall Study STARTED	37	39
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?

Baseline characteristics by cohort

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=39 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants	21 Participants n=4 Participants	40 Participants n=27 Participants
Age Continuous	65.2 years STANDARD_DEVIATION 11.0 • n=93 Participants	65.8 years STANDARD_DEVIATION 11.1 • n=4 Participants	65.5 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	23 Participants n=4 Participants	53 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	16 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment United States	37 participants n=93 Participants	39 participants n=4 Participants	76 participants n=27 Participants

PRIMARY outcome

Timeframe: days after surgery

Outcome measures

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=38 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Length of Hospital Stay	3.5 days Standard Deviation 1.9	2.6 days Standard Deviation 0.7

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=38 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Knee Range of Motion	112.5 degrees Standard Deviation 10.3	112.4 degrees Standard Deviation 12.1

PRIMARY outcome

Timeframe: 3 months postoperative

The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.

Outcome measures

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=38 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Knee Society Scores	87.1 units on a scale Standard Deviation 11.2	83.3 units on a scale Standard Deviation 14.7

PRIMARY outcome

Timeframe: Average of 3 days after surgery

Outcome measures

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=39 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Amount of Pain Medication Taken Per Day	47.8 mg/day morphine equivalant Standard Deviation 35.1	46.0 mg/day morphine equivalant Standard Deviation 22.4

PRIMARY outcome

Timeframe: 6 weeks, 3 months, and 1 year postoperative

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: any point during the first postoperative year

Outcome measures

Measure	Control Group n=37 Participants Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=39 Participants Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.	0 Number of participants with complication	3 Number of participants with complication

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Corticosteroid

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Group n=37 participants at risk Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=39 participants at risk Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Musculoskeletal and connective tissue disorders Death	0.00% 0/37 • 9 weeks One patient died 25 days after the surgery as a result of complications associated with deep knee joint sepsis. Two other patients underwent manipulation under anesthesia at a mean of 9 weeks after TKA.	2.6% 1/39 • Number of events 1 • 9 weeks One patient died 25 days after the surgery as a result of complications associated with deep knee joint sepsis. Two other patients underwent manipulation under anesthesia at a mean of 9 weeks after TKA.

Other adverse events

Measure	Control Group n=37 participants at risk Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline	Corticosteroid n=39 participants at risk Corticosteroid (methylprednisolone acetate) methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Musculoskeletal and connective tissue disorders Manipulation under anesthesia	0.00% 0/37 • 9 weeks One patient died 25 days after the surgery as a result of complications associated with deep knee joint sepsis. Two other patients underwent manipulation under anesthesia at a mean of 9 weeks after TKA.	5.1% 2/39 • Number of events 2 • 9 weeks One patient died 25 days after the surgery as a result of complications associated with deep knee joint sepsis. Two other patients underwent manipulation under anesthesia at a mean of 9 weeks after TKA.

Additional Information

Cale Jacobs, PhD

Lexington Clinic

Phone: 859-258-8238

Email: cjaco@lexclin.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place