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

Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Celecoxib (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ottawa Hospital Research Institute

Official(s) and/or principal investigator(s):
Geoff Dervin, MD, Principal Investigator, Affiliation: The Ottawa Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada
Additional Information

Starting date: February 2009
Last updated: June 16, 2014

Page last updated: August 20, 2015

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