Status:
UNKNOWN
Patella Fracture : A Randomized Controlled Trial
Lead Sponsor:
Unity Health Toronto
Conditions:
Patella Fracture
Aging
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.
Detailed Description
Patients with a displaced patellar fracture who meet the inclusion criteria and provide consent will be randomized to one of the two treatment arms. One group (Group A) will receive standardized non-o...
Eligibility Criteria
Inclusion
- Male or female patients 65 years of age or older and ambulatory prior to injury (with or without walking aids).
- Closed fracture of the patella displaced by 5 mm or greater (Displacement will be determined by measuring the widest displacement on any x-ray view with the knee in full extension).
- The patient scores between 3 and 6 on the Clinical Frailty Scale. This score corresponds to a low-demand patient who is ambulatory and functionally independent
- Within 14 days of injury, the patient is able to perform a straight leg raise with less than 30 degrees of extensor lag.
- Able to read and understand the study consent form document.
- Willing and able to sign consent, follow the study protocol and attend follow-up visits.
Exclusion
- Associated extremity injuries or polytrauma injuries that would otherwise require surgery or interfere substantially with rehabilitation or outcome in the opinion of the investigator.
- Neurovascular injuries at the level of the knee requiring surgery.
- Pathologic fractures.
- Periprosthetic fractures, or other knee surgery which would contra-indicate inclusion in the study (e.g. previous patella ORIF or previous surgery involving patella such as patella tendon or quads repair).
- Medical contra-indication to surgery.
- Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g. patients with no fixed address, intellectually challenged patients without adequate support, etc.).
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03445819
Start Date
November 1 2018
End Date
December 31 2023
Last Update
June 18 2021
Active Locations (3)
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1
London Health Sciences Centre
London, Ontario, Canada
2
St. Michael's Hospital
Toronto, Ontario, Canada
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada