Back to resultsPatella Fracture : A Randomized Controlled Trial
Primary Purpose
Patella Fracture, Aging
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group A: Surgical Treatment
Group B: Conservative Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Patella Fracture focused on measuring Patella Fracture, elderly
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.).
Sites / Locations
- London Health Sciences Centre
- St. Michael's Hospital
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A: Surgical Treatment
Group B: Conservative Treatment
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Range of Motion
Measurement of flexion and extension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03445819
Brief Title
Patella Fracture : A Randomized Controlled Trial
Official Title
A Prospective Randomized Trial of Non-operative Versus Operative Management of Patella Fractures in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella Fracture, Aging
Keywords
Patella Fracture, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Data analysts will be blinded to the study treatment.Wherever possible, outcome assessors will be blinded to the study treatment.
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Surgical Treatment
Arm Type
Other
Arm Description
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.
Arm Title
Group B: Conservative Treatment
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Group A: Surgical Treatment
Intervention Description
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
Other
Intervention Name(s)
Group B: Conservative Treatment
Intervention Description
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
1 year after injury
Secondary Outcome Measure Information:
Title
Visual Analogue Pain Scale (VAS)
Description
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)
Time Frame
1 year after injury
Title
Range of Motion
Description
Measurement of flexion and extension
Time Frame
up to 24 months
Other Pre-specified Outcome Measures:
Title
TUG Test
Description
Timed Up and Go test
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCS (C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Hall, MD, FRCS(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Citations:
PubMed Identifier
33625743
Citation
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.
Results Reference
derived
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Patella Fracture : A Randomized Controlled Trial
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