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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
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

July 27, 2011
August 11, 2011
September 2011
September 2013   (final data collection date for primary outcome measure)
Pain [ Time Frame: 12mo ] [ Designated as safety issue: No ]
Pain and function as assessed by SF-36 and Ankle Osteoarthritis Scale patient questionnaires
Same as current
Complete list of historical versions of study NCT01405664 on ClinicalTrials.gov Archive Site
CT Scan [ Time Frame: 12mo ] [ Designated as safety issue: No ]
For assessment of cartilage healing
Same as current
Not Provided
Not Provided
 
Study of the Effect of Weight Bearing Status on Patient Outcomes After Surgery for Osteochondral Defects of the Ankle
A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteochondritis Dissecans of Ankle and Joints of Foot
Other: Weight-Bearing as Tolerated
WBAT immediately after surgery
Other Name: Weight-bearing status
  • No Intervention: Non-Weight Bearing x 6 weeks
  • Experimental: Immediate Weight-Bearing as Tolerated
    Intervention: Other: Weight-Bearing as Tolerated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
68
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
16 Years to 65 Years
Yes
Contact: Trish Francis 902-473-5993 francisp@cdha.nshealth.ca
Contact: Mark Glazebrook, MD, FRCSC 902-473-7137 markglazebr@ns.sympatico.ca
Canada
 
NCT01405664
WBOCD
No
Dr. Mark Glazebrook, CDHA
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Mark Glazebrook, MD,FRCSC Capital District Health Authority, Canada
Capital District Health Authority, Canada
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP