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

Nova Scotia Health Authority (NSHA)

Status: Completed

Conditions: Osteochondritis Dissecans of Ankle and Joints of Foot

Treatments: Other: Weight-Bearing as Tolerated

Study type: Interventional

Funder types: Other

Identifiers

NCT01405664

WBOCD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Non-Weight Bearing x 6 weeks

No Intervention group

Immediate Weight-Bearing as Tolerated

Experimental group

Treatment:

Other: Weight-Bearing as Tolerated