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

NCT01405664 | Completed

• 1 other identifier: WBOCD
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondritis Dissecans of Ankle and Joints of Foot

Outcome Measures

Primary Outcomes (1)

• Ankle Osteoarthritis Scale

  Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability

  12 months

Secondary Outcomes (1)

• CAT Scan

  12months

Study Arms (2)

Non-Weight Bearing x 6 weeks

NO INTERVENTION

Immediate Weight-Bearing as Tolerated

EXPERIMENTAL

Other: Weight-Bearing as Tolerated

Interventions

Weight-Bearing as Tolerated OTHER

WBAT immediately after surgery

Also known as: Weight-bearing status

Immediate Weight-Bearing as Tolerated

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Halifax, Nova Scotia, B3H3A7, Canada

Location

MeSH Terms

Interventions

Weight-Bearing

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Mark Glazebrook, MD,FRCSC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: September 1, 2011
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: August 21, 2024

Record last verified: 2022-03

Locations

CA (1)