Patella Fracture : A Randomized Controlled Trial

NCT03445819 | Unknown

• 1 other identifier: Patella RCT 2018
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Patella Fracture; Aging

Keywords

Patella Fracture, elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year after injury

Secondary Outcomes (2)

• Visual Analogue Pain Scale (VAS)

  1 year after injury

• Range of Motion

  up to 24 months

Other Outcomes (1)

• TUG Test

  up to 24 months

Study Arms (2)

Group A: Surgical Treatment

OTHER

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

Group B: Conservative Treatment

OTHER

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

Interventions

Group A: Surgical Treatment 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 A: Surgical Treatment

Group B: Conservative Treatment OTHER

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

Group B: Conservative Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.).

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (3)

London Health Sciences Centre

London, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 33625743 DERIVED

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Aaron Nauth, MD, FRCS (C)

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Jeremy Hall, MD, FRCS(C)

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will be blinded to the study treatment.Wherever possible, outcome assessors will be blinded to the study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 26, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)