A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament (ACL) Reconstruction

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Celecoxib; Drug: Placebo

• Registration Number: NCT01186887
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

The aim of this study is to directly compare the clinical outcomes of both the celecoxib and placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have short and long term goals. Validated outcome measures will aim to quantify pain control at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared using pain control scales, and functional knee outcome scores. The first null hypothesis tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. The second null hypothesis is that no knee function difference will be found between the celecoxib and placebo groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Any patient 18 years and over undergoing primary anterior cruciate ligament reconstruction with hamstring grafts will be considered for this study.

Exclusion Criteria

• Patients will be excluded if they have bilateral ACL injuries, require revision ACL reconstruction, require meniscus repair, have multiple ligament injuries, gross osteoarthritis, significant clinical malalignment or if they cannot attend appropriate follow-up. Other exclusion criteria will include use of a regional block during the surgery, a diagnosis of esophageal, gastric, or duodenal ulceration, hepatic disease, renal disease, hypertension, hypersensitivity to Celecoxib, known allergic-type reactions to sulfonamides, known allergies to ASA or other NSAIDS, inflammatory bowel disease or hyperkalemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is to test the null hypothesis that Celecoxib perioperatively does not negatively influence the static testing of ACL reconstruction as measured by KT arthrometer at 2 years post op.	2 years

Secondary Outcome Measures

Name	Time	Method
The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group.	2 years

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada