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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 65 Years (Child, 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Mark Glazebrook, CDHA
ClinicalTrials.gov Identifier:	NCT01405664 History of Changes
Other Study ID Numbers:	WBOCD
First Posted:	July 29, 2011
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