Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
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|ClinicalTrials.gov Identifier: NCT00492973|
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Post-traumatic; Arthrosis||Drug: methylprednisolone acetate Drug: active comparator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Active Comparator: Control
Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.
Drug: active comparator
bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate)
Drug: methylprednisolone acetate
Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
- Length of Hospital Stay [ Time Frame: days after surgery ]
- Knee Range of Motion [ Time Frame: 3 months ]
- Knee Society Scores [ Time Frame: 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 [ Time Frame: Average of 3 days after surgery ]
- Patient Satisfaction [ Time Frame: 6 weeks, 3 months, and 1 year postoperative ]
- Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc. [ Time Frame: any point during the first postoperative year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492973
|United States, Kentucky|
|Lexington Clinic Sports Medicine Center|
|Lexington, Kentucky, United States, 40504|
|Principal Investigator:||Christian P Christensen, MD||New Lexington Clinic|