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Clinical Trials/NCT01186887
NCT01186887CompletedNot Applicable

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

Ottawa Hospital Research Institute1 site in 1 country40 target enrollmentStarted: February 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Celecoxib

Placebo Comparator

Intervention: Celecoxib (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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.

Time Frame: 2 years

Secondary Outcomes

  • The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group.(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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