Clinical Trial: Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy

Brief Summary: In a brief summary the study would like to evaluate the effectiveness of Naproxen in preventing radiographically detected heterotopic ossification following hip arthroscopy for the treatment of femoroacetabular impingement.

Detailed Summary:

Heterotopic bone formation (HO) is a potentially serious complication of hip surgery. HO, defined as the formation of normal bone in an abnormal soft tissue location, results from alteration in the normal regulation of skeletogenesis. Although most patients remain asymptomatic despite HO development, two articles that included 10,826 patients from 37 studies suggest HO may be associated with substantial compromise of function and range of motion even at low grades.In a large pooled incidence study, HO was estimated to be 43% in 59,121 patients undergoing total hip arthroplasty, and 51% in 998 patients after acetabular trauma.

Few studies have reported on the incidence of HO following hip arthroscopy. However, HO is an increasingly reported complication of arthroscopic treatment for femoroacetabular impingement(FAI). In a comparison of complications following arthroscopic treatment of FAI in 8 case-series, ectopic ossification occurred in up to 6% of cases and accounted for 10 of the 19 reported complications. Additionally, one recent study reported an HO incidence of 33% (5 out of 15 patients) following hip arthroscopy in patients not prophylaxed with NSAID therapy. In our experience, HO occurs at a comparable or higher rate of 10% in those undergoing this procedure. The formation of ectopic ossification is triggered as a result of muscle damage during introduction of hip portals and is potentially augmented by seeding of bone shavings in the soft tissues created during burring of the femoral neck.

Prophylaxis of HO targets the biochemical mechanisms of heterotopic bone formation by: 1) Disrupting inductive signaling pathways, 2) Altering osteoprogenitor cells in target tissues, and 3) Modifying the environment conductive to formation of heteroptic bone. The two mainstays of therapy are low dose radiation treatment and non
Sponsor: University of Utah

Current Primary Outcome: Number of participants with documented Heterotopic Ossification (HO) in the Naproxen group vs Placebo group [ Time Frame: 75 days after surgery ]

The hypothesis is that there will be fewer instances of HO in the Naproxen group compared to the Placebo group.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse events in the Naproxen group vs Placebo group. [ Time Frame: Data outcome collected 4 weeks post operatively ]

Adverse events include GI upset, GI bleed, Kidney failure, Drug reactions and Healing problems.


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: January 12, 2012
Date Started: January 2012
Date Completion: January 2019
Last Updated: February 28, 2017
Last Verified: February 2017