Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 11/30/2013 |
| Start Date: | March 2006 |
| End Date: | June 2009 |
| Contact: | Cale A Jacobs, PhD |
| Email: | cjaco@lexclin.com |
| Phone: | (859)258-8560 |
Peri-Articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
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.
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.
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
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