Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, B3H3A7, Canada
Completed
NCT Number: NCT01405664
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for 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.
Completed
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Notify MeKey information
Age range
16 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Weight-Bearing as Tolerated
OtherWBAT immediately after surgery
Other names: Weight-bearing status
Primary outcomes
-
Ankle Osteoarthritis Scale
Time frame: 12 months
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability
Secondary outcomes
-
CAT Scan
Time frame: 12months
For assessment of cartilage healing
Sponsors and collaborators
Lead sponsor
Nova Scotia Health Authority
Other
Registry information
Official study 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
Important dates
- Study start
- 2011
- Primary completion
- 2022
- Study completion
- 2023
- First posted
- Jul 29, 2011
- Registry last updated
- Aug 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.