the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Osteochondritis Dissecans of Ankle and Joints of Foot

Intervention / Treatment
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* Other: Weight-Bearing as Tolerated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 16-60 years No prior ankle surgery Able and willing to comply with follow-up Capable of provide informed consent Medically fit for surgery Lesions on preoperative CT Scan < 1.5cm Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM) Single Isolated lesion Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization) Exclusion Criteria: Age less than 16 years or greater than 60 years Inflammatory arthritis Diffuse osteoarthritis of affected joint Associated fracture Prior ankle surgery for current injury (including arthroscopy) Unable to comply with follow-up Unable to provide informed consent Bernt & Hardy class IV (amenable to ORIF) Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus Prior osteochondral defects of the affected ankle

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Weight Bearing x 6 weeks<br> | |
| Experimental: Immediate Weight-Bearing as Tolerated<br> | Other: Weight-Bearing as Tolerated<br>* WBAT immediately after surgery<br>* Other names: Weight-bearing status;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle Osteoarthritis Scale | Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAT Scan | For assessment of cartilage healing | 12months |