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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 27, 2011 | ||||||||
| Last Updated Date | August 11, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain [ Time Frame: 12mo ] [ Designated as safety issue: No ] Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01405664 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
CT Scan [ Time Frame: 12mo ] [ Designated as safety issue: No ] For assessment of cartilage healing |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle | ||||||||
| Official Title ICMJE | A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteochondritis Dissecans of Ankle and Joints of Foot | ||||||||
| Intervention ICMJE | Other: Weight-Bearing as Tolerated
WBAT immediately after surgery
Other Name: Weight-bearing status |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 68 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Age less than 16 years or greater than 60 years
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| Gender | Both | ||||||||
| Ages | 16 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01405664 | ||||||||
| Other Study ID Numbers ICMJE | WBOCD | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Mark Glazebrook, CDHA | ||||||||
| Study Sponsor ICMJE | Capital District Health Authority, Canada | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Capital District Health Authority, Canada | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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