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

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ClinicalTrials.gov Identifier: NCT01405664
Recruitment Status : Unknown
Verified July 2011 by Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2011
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:
Nova Scotia Health Authority

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteochondritis Dissecans of Ankle and Joints of Foot Other: Weight-Bearing as Tolerated Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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 Name: Weight-bearing status


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: 12mo ]
    Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires


Secondary Outcome Measures :
  1. CT Scan [ Time Frame: 12mo ]
    For assessment of cartilage healing


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Nova Scotia Health Authority
Investigators
Principal Investigator: Mark Glazebrook, MD,FRCSC Nova Scotia Health Authority
More Information
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Responsible Party: Dr. Mark Glazebrook, CDHA
ClinicalTrials.gov Identifier: NCT01405664     History of Changes
Other Study ID Numbers: WBOCD
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: July 2011

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