Naproxen for the Prevention of HO After Complex Elbow Trauma (Naproxen)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial|
- There is no difference in ulnohumeral flexion [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Will receive 500 mg Naproxen twice a day for two weeks
500 mg Naproxen twice a day for two weeks
No Intervention: 2
Will not receive naproxen
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586365
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Study Director:||David Ring, MD PhD||Mass General|