Patella Fracture : A Randomized Controlled Trial

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

This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Patella Fracture
• Intervention / Treatment: Procedure: Group A: Surgical Treatment; Other: Group B: Conservative Treatment

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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. 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; Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year after injury
Range of Motion	Measurement of flexion and extension	up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TUG Test	Timed Up and Go test	up to 24 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Aaron Nauth, MD, FRCS (C), Unity Health Toronto; Principal Investigator: Jeremy Hall, MD, FRCS(C), Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Patella Fracture, elderly
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Patella RCT 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No