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

NCT ID: NCT01405664

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-01
• Study Completion Date: 2023-09-30

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.

Conditions

Osteochondritis Dissecans of Ankle and Joints of Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-Weight Bearing x 6 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Immediate Weight-Bearing as Tolerated

Group Type: EXPERIMENTAL

Weight-Bearing as Tolerated

Intervention Type: OTHER

WBAT immediately after surgery

Interventions

Weight-Bearing as Tolerated

WBAT immediately after surgery

Intervention Type: OTHER

Other Intervention Names

Weight-bearing status

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Glazebrook, MD,FRCSC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

WBOCD

Identifier Type: -

Identifier Source: org_study_id