This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
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
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
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.
Time frame: 1 year after injury
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)
Time frame: 1 year after injury
Range of Motion
Measurement of flexion and extension
Time frame: up to 24 months
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