Clinical trial NCT00492973: Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
Official title: Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Post-traumatic; Arthrosis
Keywords: arthroplasty
replacement
knee
Lead sponsor: New Lexington Clinic
Sponsor class: OTHER
Collaborators: name: St. Joseph's Health Care London
First posted: 2007-06-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: days after surgery
measure: Knee Range of Motion
timeFrame: 3 months
measure: Knee Society Scores
timeFrame: 3 months postoperative
measure: Amount of Pain Medication Taken Per Day
timeFrame: Average of 3 days after surgery
measure: Patient Satisfaction
timeFrame: 6 weeks, 3 months, and 1 year postoperative
measure: Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
timeFrame: any point during the first postoperative year
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lexington Clinic Sports Medicine Center
state: Kentucky
Study officials:
affiliation: New Lexington Clinic
name: Christian P Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.
citation: Parvataneni HK, Ranawat AS, Ranawat CS. The use of local periarticular injections in the management of postoperative pain after total hip and knee replacement: a multimodal approach. Instr Course Lect. 2007;56:125-31.
citation: Christensen CP, Jacobs CA, Jennings HR. Effect of periarticular corticosteroid injections during total knee arthroplasty. A double-blind randomized trial. J Bone Joint Surg Am. 2009 Nov;91(11):2550-5. doi: 10.2106/JBJS.H.01501.