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

August 19, 2024 updated by: Nova Scotia Health Authority

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-Weight Bearing x 6 weeks
Experimental: Immediate Weight-Bearing as Tolerated
Other: Weight-Bearing as Tolerated
WBAT immediately after surgery
Other Names:
  • Weight-bearing status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Osteoarthritis Scale
Time Frame: 12 months
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAT Scan
Time Frame: 12months
For assessment of cartilage healing
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Mark Glazebrook, MD,FRCSC, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimated)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBOCD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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