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

Primary Purpose

Osteochondritis Dissecans of Ankle and Joints of Foot

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Weight-Bearing as Tolerated
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteochondritis Dissecans of Ankle and Joints of Foot

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre, Halifax InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-Weight Bearing x 6 weeks

Immediate Weight-Bearing as Tolerated

Arm Description

Outcomes

Primary Outcome Measures

Ankle Osteoarthritis Scale
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability

Secondary Outcome Measures

CAT Scan
For assessment of cartilage healing

Full Information

First Posted
July 27, 2011
Last Updated
July 14, 2020
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01405664
Brief Title
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2011 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteochondritis Dissecans of Ankle and Joints of Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Weight Bearing x 6 weeks
Arm Type
No Intervention
Arm Title
Immediate Weight-Bearing as Tolerated
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Weight-Bearing as Tolerated
Other Intervention Name(s)
Weight-bearing status
Intervention Description
WBAT immediately after surgery
Primary Outcome Measure Information:
Title
Ankle Osteoarthritis Scale
Description
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CAT Scan
Description
For assessment of cartilage healing
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trish Francis
Phone
902-473-5993
Email
francisp@cdha.nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Glazebrook, MD, FRCSC
Phone
902-473-7137
Email
markglazebr@ns.sympatico.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Glazebrook, MD,FRCSC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trish Francis
Phone
902-473-5993
Email
francip@cdha.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Mark Glazebrook, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Caroline A Tougas, MD

12. IPD Sharing Statement

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

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