Status:
COMPLETED
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Osteochondritis Dissecans of Ankle and Joints of Foot
Eligibility:
All Genders
16-65 years
Phase:
NA
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 p...
Detailed Description
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 betw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01405664
Start Date
September 1 2011
End Date
September 30 2023
Last Update
August 21 2024
Active Locations (1)
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1
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H3A7