Aging Clinical Trial
Official title:
A Prospective Randomized Trial of Non-operative Versus Operative Management of Patella Fractures in the Elderly
Verified date | June 2021 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.
Status | Active, not recruiting |
Enrollment | 84 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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.). |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | TUG Test | Timed Up and Go test | up to 24 months | |
Primary | Knee injury and Osteoarthritis Outcome Score (KOOS) | A self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 1 year after injury | |
Secondary | Visual Analogue Pain Scale (VAS) | VAS consists of a straight line with the endpoints defining extreme limits of pain, ranging from 'no pain at all' (zero) to 'pain as bad as it could be' (10) | 1 year after injury | |
Secondary | Range of Motion | Measurement of flexion and extension | up to 24 months |
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