Clinical Trial: Naproxen for the Prevention of HO After Complex Elbow Trauma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial

Brief Summary:

Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.

Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.

The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: There is no difference in ulnohumeral flexion [ Time Frame: 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: December 14, 2007
Date Started: October 2007
Date Completion:
Last Updated: March 20, 2012
Last Verified: March 2012