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

Not Applicable

Completed

• Conditions: Osteochondritis Dissecans of Ankle and Joints of Foot
• Interventions: Other: Weight-Bearing as Tolerated

• Registration Number: NCT01405664
• Lead Sponsor: Nova Scotia Health Authority

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 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 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 Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Study Start: 2011-09-01
• Status Verified: 2022-03
• Primary Completion: 2022-09-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Weight-Bearing as Tolerated	Weight-Bearing as Tolerated	-

Primary Outcome Measures

Name	Time	Method
Ankle Osteoarthritis Scale	12 months	Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability

Secondary Outcome Measures

Name	Time	Method
CAT Scan	12months	For assessment of cartilage healing

Trial Locations

Locations (1)

Queen Elizabeth II Health Sciences Centre, Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada