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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01405664
Recruitment Status : Recruiting
First Posted : July 29, 2011
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Glazebrook, Nova Scotia Health Authority

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.

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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
Actual Study Start Date : September 1, 2011
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023


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




Primary Outcome Measures :
  1. 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


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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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 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

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

Locations
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Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary 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
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Principal Investigator: Mark Glazebrook, MD,FRCSC Nova Scotia Health Authority
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Responsible Party: Mark Glazebrook, MD, FRCSC Orthopedic Surgery, Foot & Ankle, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01405664    
Other Study ID Numbers: WBOCD
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases