Reverse or Primary Total Shoulder Clinical Trial
Official title:
Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery: A Randomized Controlled Study
| Verified date | April 2018 |
| Source | St. Louis Joint Replacement Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | June 2018 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion / Exclusion Criteria for Pfizer Study Inclusion Criteria: 1. community ambulators 2. D/C to home only 3. only MO and IL pts 4. Primary unilateral shoulder replacements / Cuff tear 5. Full Thickness, single tendon tear Exclusion Criteria: 1. allergy, sensitivity, or inability to take Celebrex 2. CR >1.5 3. h/o bleeding ulcers 4. h/o Inflammatory bowel disease, Crohn's disease, ulcerative colitis 5. Coagulation abnormality 6. Coumadin/Plavix/Xaralto 7. CHF 8. Previous MI or CVA 9. Current use of long acting narcotics (Fentanyl Patches, Oxycontin CR, MS Contin) 10. Refusal by PCP or cardiologist |
| Country | Name | City | State |
|---|---|---|---|
| United States | SSM DePaul | Bridgeton | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| St. Louis Joint Replacement Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption. | 3 weeks | ||
| Primary | This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption. | 6 weeks |