4 Clinical Trials for Various Conditions
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively. Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.
Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.
Purpose of Study: To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion. The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA. The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side. In all cases, a deltopectoral incision will be used as the procedure type.