A Prospective Randomized Trial of Non-operative Versus Operative Management of Patella Fractures in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Unity Health Toronto
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- Knee injury and Osteoarthritis Outcome Score (KOOS)
Study Overview
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-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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data analysts will be blinded to the study treatment.Wherever possible, outcome assessors will be blinded to the study treatment.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.).
Outcomes
Primary Outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 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 Outcomes
- Visual Analogue Pain Scale (VAS)(1 year after injury)
- Range of Motion(up to 24 months)