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

Osteochondritis Dissecans of Ankle and Joints of Foot Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01405664
• Other study ID #: WBOCD
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2011
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2020
• Source: Nova Scotia Health Authority
• Contact: Trish Francis
• Phone: 902-473-5993
• Email: francisp[@]cdha.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis Dissecans
• Osteochondritis Dissecans of Ankle and Joints of Foot

Intervention

Other:
• Weight-Bearing as Tolerated
WBAT immediately after surgery

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre, Halifax Infirmary	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle Osteoarthritis Scale	Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability	12 months
Secondary	CAT Scan	For assessment of cartilage healing	12months