Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01405664
First received: July 27, 2011
Last updated: August 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Osteochondritis Dissecans of Ankle and Joints of Foot
Other: Weight-Bearing as Tolerated

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Pain [ Time Frame: 12mo ] [ Designated as safety issue: No ]
    Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires


Secondary Outcome Measures:
  • CT Scan [ Time Frame: 12mo ] [ Designated as safety issue: No ]
    For assessment of cartilage healing


Estimated Enrollment: 68
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non-Weight Bearing x 6 weeks
Experimental: Immediate Weight-Bearing as Tolerated Other: Weight-Bearing as Tolerated
WBAT immediately after surgery
Other Name: Weight-bearing status

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 OA 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 OCDs in one ankle or Touching osteochondral lesions of tibia and talus
  • Prior OCD of the affected ankle
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405664

Contacts
Contact: Trish Francis 902-473-5993 francisp@cdha.nshealth.ca
Contact: Mark Glazebrook, MD, FRCSC 902-473-7137 markglazebr@ns.sympatico.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary Not yet recruiting
Halifax, Nova Scotia, Canada, B3H3A7
Contact: Trish Francis    902-473-5993    francip@cdha.nshealth.ca   
Principal Investigator: Mark Glazebrook, MD, FRCSC         
Sub-Investigator: Caroline A Tougas, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Mark Glazebrook, MD,FRCSC Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Dr. Mark Glazebrook, CDHA
ClinicalTrials.gov Identifier: NCT01405664     History of Changes
Other Study ID Numbers: WBOCD
Study First Received: July 27, 2011
Last Updated: August 11, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Osteochondritis
Osteochondritis Dissecans
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on October 19, 2014