Patella Fracture : A Randomized Controlled Trial

NCT ID: NCT03445819

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2023-12-31

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.

Conditions

Patella Fracture; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Group A: Surgical Treatment

Intervention Type: PROCEDURE

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

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

Group Type: OTHER

Group B: Conservative Treatment

Intervention Type: OTHER

Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.

Interventions

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

Intervention Type: PROCEDURE

Group B: Conservative Treatment

Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.

Intervention Type: OTHER

Eligibility Criteria

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.).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Nauth, MD, FRCS (C)

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Jeremy Hall, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

London Health Sciences Centre

London, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Sayum Filho J, Lenza M, Tamaoki MJ, Matsunaga FT, Belloti JC. Interventions for treating fractures of the patella in adults. Cochrane Database Syst Rev. 2021 Feb 24;2(2):CD009651. doi: 10.1002/14651858.CD009651.pub3.

Reference Type: DERIVED

PMID: 33625743 (View on PubMed)

Other Identifiers

Patella RCT 2018

Identifier Type: -

Identifier Source: org_study_id