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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01405664
Enrollment
68
Registered
2011-07-29
Start date
2011-09-01
Completion date
2023-09-30
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteochondritis Dissecans of Ankle and Joints of Foot

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.

Interventions

WBAT immediately after surgery

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ankle Osteoarthritis Scale12 monthsPain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability

Secondary

MeasureTime frameDescription
CAT Scan12monthsFor assessment of cartilage healing

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026