Clinical Trial: Bisphosphonates and Impaction Grafting in Hip Revision

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

Official Title: Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Os

Brief Summary: The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.

Detailed Summary:

Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.

We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.

Sponsor: Region Skane

Current Primary Outcome: Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion) [ Time Frame: 12-24 months ]

Original Secondary Outcome: Same as current

Information By: Region Skane

Dates:
Date Received: April 9, 2008
Date Started: March 2008
Date Completion: March 2012
Last Updated: January 26, 2012
Last Verified: January 2012