NCT03445819

Patella Fracture : A Randomized Controlled Trial

A Prospective Randomized Trial of Non-operative Versus Operative Management of Patella Fractures in the Elderly

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patella Fracture
• Aging

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2018-02-26
• Last updated: 2021-06-18

Locations

3 sites across 1 country: Canada