Title
Randomised, controlled clinical trial to evaluate the effect on patient outcomes of weight bearing status after arthroscopic forage of osteochondral defects of the ankle
Last Updated: March 22/2017
Decscription/ Level of evidence
Eligibility
Inclusion Criteria:
- Ages 16-60 years
- Medically fit for surgery
- No prior ankle surgery
- Osteochondral lesions confirmed on preoperative CT Scan < 1.5cm
- Symptomatic (pain, restricted activities, inability to weight bear, decreased range of motion)
- Primary isolated lesion
- Failure of conservative treatment (3 mo limited activities, weight bearing and/or immobilization)
- Able and willing to comply with follow-up
- Capable of providing informed consent
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)
- Bernt & Hardy class IV lesion (amenable to ORIF)
- Multiple osteochondral defects
- Touching osteochondral lesions of the tibia and talus
- Prior osteochondral defect of the affected ankle
- Unable to comply with follow-up
- Unable to provide informed consent
Sample Size calculation:
Sample size=69 Enrollment=29
Status: currently enrolling
Outcome Measures
The impact of treatment will be analyzed using the Ankle Osteoarthritis Scale (AOS) and the Short-Form Health Survey (SF-36)/ CT scan or MRI will be the secondary outcome measure.
Contacts
Principal Investigator
Dr Mark Glazebrook -markglazebr@hotmail.ca
Clinical Research Coordinator -Trish Francis RN 902-473-4136, Pager 902-458-0213 Trish.Francis@nshealth.ca
Funding
Unfunded Investigator Initiated
Anticipated Closing date: Dec31/2019
Review:
Authors: Carolyn Tougas/Mark Glazebrook
Presentations:
Publications: