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Conservative vs Surgical Treatment for Knee Fracture
N/A
Waitlist Available
Led By Aaron Nauth, MD, FRCS (C)
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after injury
Awards & highlights
Study Summary
This trial is comparing two different treatments for patella fractures in elderly patients who are not very active.
Who is the study for?
This trial is for people aged 65 or older who had a patella (knee cap) fracture that's moved out of place by at least 5mm. They should have been able to walk before the injury, even with aids, and be somewhat active but not overly demanding physically. Participants must understand and consent to the study, be within two weeks of their injury, and capable of lifting their leg straight up.Check my eligibility
What is being tested?
The study compares surgical versus non-surgical treatments for knee cap fractures in elderly patients who don't demand much from their bodies. It's conducted across multiple centers where participants are randomly assigned to one of the treatment groups.See study design
What are the potential side effects?
Surgical treatment may lead to risks like infection, bleeding, or reaction to anesthesia; while conservative treatment might result in less immediate risk but could potentially lead to longer-term mobility issues or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after injury
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee
Secondary outcome measures
Range of Motion
Visual Analogue Pain Scale (VAS)
Other outcome measures
TUG Test
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B: Conservative TreatmentExperimental Treatment1 Intervention
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 II: Group A: Surgical TreatmentExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
537 Previous Clinical Trials
447,455 Total Patients Enrolled
1 Trials studying Knee Fracture
148 Patients Enrolled for Knee Fracture
Aaron Nauth, MD, FRCS (C)Principal InvestigatorUnity Health Toronto
Jeremy Hall, MD, FRCS(C)Principal InvestigatorUnity Health Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Group B: Conservative Treatment
- Group 2: Group A: Surgical Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join this research at the present time?
"As reported on clinicaltrials.gov, this medical research is not presently looking for new patients as the last update was posted on June 16th 2021. Though no longer enrolling participants, there are still 591 other studies actively recruiting individuals at present."
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