Patella Fracture : A Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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-operative treatment with immediate weight-bearing as tolerated in a knee immobilizer and early ROM exercises begun at 2 weeks post injury. The other group (Group B) will receive ORIF of their displaced patellar fracture with a standardized post-operative protocol.
Post-operative rehabilitation will be standardized across both groups. Patients will be weight bearing as tolerated immediately in a removable knee immobilizer, with progressive range-of-motion exercises begun at two weeks following surgery or randomization. The knee immobilizer will be used full-time (with the exception of removal for physiotherapy and bathing) for 6 weeks after surgery or randomization. At six weeks post-treatment, patients will be allowed to perform active extension and will initiate progressive strengthening exercises of the extensor mechanism.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Group A: Surgical Treatment Open reduction and internal fixation (ORIF) of the patellar fracture will be performed using screws, wires, pins, or plate fixation at the discretion of the treating surgeon. The trial is designed in a pragmatic fashion to allow participating surgeons from the multiple participating sites to perform fixation as per the standard of care at their institution. Post-operative care will include standard-of-care antibiotics and deep vein thrombosis (DVT) prophylaxis, both prescribed at the discretion of the attending surgeon. |
Procedure: Group A: Surgical Treatment
Open reduction and internal fixation (ORIF) of the patellar fracture will be performed using screws, wires, pins, or plate fixation at the discretion of the treating surgeon
|
| Other: Group B: Conservative Treatment Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery. Patients will be weight bearing as tolerated immediately in a removable knee immobilizer, with progressive range-of-motion exercises begun at two weeks following randomization |
Other: Group B: Conservative Treatment
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.
|
Outcome Measures
Primary Outcome Measures
- Knee injury and Osteoarthritis Outcome Score (KOOS) [1 year after injury]
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.
Secondary Outcome Measures
- Visual Analogue Pain Scale (VAS) [1 year after injury]
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)
- Range of Motion [up to 24 months]
Measurement of flexion and extension
Other Outcome Measures
- TUG Test [up to 24 months]
Timed Up and Go test
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients 65 years of age or older and ambulatory prior to injury (with or without walking aids).
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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).
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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
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Within 14 days of injury, the patient is able to perform a straight leg raise with less than 30 degrees of extensor lag.
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Able to read and understand the study consent form document.
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Willing and able to sign consent, follow the study protocol and attend follow-up visits.
Exclusion Criteria:
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Associated extremity injuries or polytrauma injuries that would otherwise require surgery or interfere substantially with rehabilitation or outcome in the opinion of the investigator.
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Neurovascular injuries at the level of the knee requiring surgery.
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Pathologic fractures.
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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).
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Medical contra-indication to surgery.
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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.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre | London | Ontario | Canada | |
| 2 | St. Michael's Hospital | Toronto | Ontario | Canada | |
| 3 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Unity Health Toronto
Investigators
- Principal Investigator: Aaron Nauth, MD, FRCS (C), Unity Health Toronto
- Principal Investigator: Jeremy Hall, MD, FRCS(C), Unity Health Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Patella RCT 2018