Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Post-Traumatic Arthritis |
Drug: methylprednisolone acetate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Peri-Articular Injections Containing a Corticosteroid During Total Knee Arthroplasty |
- Length of hospital stay [ Time Frame: days after surgery ]
- Knee range of motion [ Time Frame: baseline (preoperative), 6 weeks, 3 months, and one year postoperative ]
- Knee Society Scores [ Time Frame: Baseline (preoperative), 6 weeks, 3 months, and 1 year postoperative ]
- Complications such as manipulations under anesthesia, revision surgeries, infections, etc. [ Time Frame: within the first postoperative year ]
- Amount of pain medication taken per day [ Time Frame: during hospital stay ]
- Patient satisfaction [ Time Frame: 6 weeks, 3 months, and 1 year postoperative ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Cale A Jacobs, PhD | (859)258-8560 | cjaco@lexclin.com |
| United States, Kentucky | |
| Lexington Clinic Sports Medicine Center | Recruiting |
| Lexington, Kentucky, United States, 40504 | |
| Contact: Cale A Jacobs, PhD 859-258-8560 cjaco@lexclin.com | |
| Principal Investigator: Cale A Jacobs, PhD | |
| Principal Investigator: Christian P Christensen, MD | |
| Principal Investigator: | Cale A Jacobs, PhD | New Lexington Clinic |
| Principal Investigator: | Christian P Christensen, MD | New Lexington Clinic |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00492973 History of Changes |
| Other Study ID Numbers: | LCO.2006.2 |
| Study First Received: | June 25, 2007 |
| Last Updated: | June 25, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Lexington Clinic:
|
arthroplasty replacement knee |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013