Clinical Trial: Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle

Brief Summary:

The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.

The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.


Detailed Summary:

The hypothesis for advantage of the investigational post-operative therapy is based on:

Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.


Sponsor: Nova Scotia Health Authority

Current Primary Outcome: Pain [ Time Frame: 12mo ]

Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires


Original Primary Outcome: Same as current

Current Secondary Outcome: CT Scan [ Time Frame: 12mo ]

For assessment of cartilage healing


Original Secondary Outcome: Same as current

Information By: Nova Scotia Health Authority

Dates:
Date Received: July 27, 2011
Date Started: September 2011
Date Completion: September 2013
Last Updated: August 11, 2011
Last Verified: July 2011