Osteoarthritis, Post-traumatic; Arthrosis
Conditions
Keywords
arthroplasty, replacement, knee
Brief summary
Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.
Detailed description
Information collected during your office visits: The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery. Injection during total knee replacement surgery: All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection. Information being collected during your hospital stay: During the hospital stay, information will be gathered for this study. A physical therapist will measure how well the patient can bend and straighten the knee. The amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.
Interventions
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
DRUGactive comparator
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
Sponsors
St. Joseph's Health Care London
New Lexington Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Between ages of 18 and 95 * Has elected to undergo total knee replacement
Exclusion criteria
* Allergy to any of the medications used in the protocol * History of kidney disease * Rheumatoid arthritis * Any systemic conditions associated with chronic pain * History of deep knee sepsis in the affected extremity * Unable to understand the questions used to obtain the Knee Society Score * Minors and prisoners will be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | days after surgery | — |
| Knee Range of Motion | 3 months | — |
| Knee Society Scores | 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. |
| Amount of Pain Medication Taken Per Day | Average of 3 days after surgery | — |
| Patient Satisfaction | 6 weeks, 3 months, and 1 year postoperative | — |
| Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. | any point during the first postoperative year | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| Corticosteroid Corticosteroid (methylprednisolone acetate)
methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate | 39 |
| Total | 76 |
Baseline characteristics
| Characteristic | Corticosteroid | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age Continuous | 65.8 years STANDARD_DEVIATION 11.1 | 65.2 years STANDARD_DEVIATION 11 | 65.5 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 39 participants | 37 participants | 76 participants |
| Sex: Female, Male Female | 23 Participants | 30 Participants | 53 Participants |
| Sex: Female, Male Male | 16 Participants | 7 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 2 / 39 |
| serious Total, serious adverse events | 0 / 37 | 1 / 39 |
Outcome results
Primary
Amount of Pain Medication Taken Per Day
Time frame: Average of 3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Amount of Pain Medication Taken Per Day | 47.8 mg/day morphine equivalant | Standard Deviation 35.1 |
| Corticosteroid | Amount of Pain Medication Taken Per Day | 46.0 mg/day morphine equivalant | Standard Deviation 22.4 |
Primary
Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
Time frame: any point during the first postoperative year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. | 0 Number of participants with complication |
| Corticosteroid | Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. | 3 Number of participants with complication |
Primary
Knee Range of Motion
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knee Range of Motion | 112.5 degrees | Standard Deviation 10.3 |
| Corticosteroid | Knee Range of Motion | 112.4 degrees | Standard Deviation 12.1 |
Primary
Knee Society Scores
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.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knee Society Scores | 87.1 units on a scale | Standard Deviation 11.2 |
| Corticosteroid | Knee Society Scores | 83.3 units on a scale | Standard Deviation 14.7 |
Primary
Length of Hospital Stay
Time frame: days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Length of Hospital Stay | 3.5 days | Standard Deviation 1.9 |
| Corticosteroid | Length of Hospital Stay | 2.6 days | Standard Deviation 0.7 |
Primary
Patient Satisfaction
Time frame: 6 weeks, 3 months, and 1 year postoperative