Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle
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|ClinicalTrials.gov Identifier: NCT01405664|
Recruitment Status : Unknown
Verified July 2011 by Nova Scotia Health Authority.
Recruitment status was: Not yet recruiting
First Posted : July 29, 2011
Last Update Posted : August 12, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteochondritis Dissecans of Ankle and Joints of Foot||Other: Weight-Bearing as Tolerated||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
|No Intervention: Non-Weight Bearing x 6 weeks|
|Experimental: Immediate Weight-Bearing as Tolerated||
Other: Weight-Bearing as Tolerated
WBAT immediately after surgery
Other Name: Weight-bearing status
- Pain [ Time Frame: 12mo ]Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires
- CT Scan [ Time Frame: 12mo ]For assessment of cartilage healing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405664
|Contact: Trish Francisfirstname.lastname@example.org|
|Contact: Mark Glazebrook, MD, FRCSCemail@example.com|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre, Halifax Infirmary||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H3A7|
|Contact: Trish Francis 902-473-5993 firstname.lastname@example.org|
|Principal Investigator: Mark Glazebrook, MD, FRCSC|
|Sub-Investigator: Caroline A Tougas, MD|
|Principal Investigator:||Mark Glazebrook, MD,FRCSC||Nova Scotia Health Authority|