Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle
This study is not yet open for participant recruitment.
Verified July 2011 by Capital District Health Authority, Canada
Sponsor:
Capital District Health Authority, Canada
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
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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:
Genetics Home Reference related topics:
familial osteochondritis dissecans
MedlinePlus related topics:
Foot Health
U.S. FDA Resources
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
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 Bone Diseases |
Musculoskeletal Diseases Cartilage Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 16, 2013