An interventional study of Group A: Surgical Treatment and Group B: Conservative Treatment in Patella Fracture and Aging, sponsored by Unity Health Toronto. Status unknown at 3 sites in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.
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.
40 studies on the registry are indexed under Patella Fracture; 9 are open to participants now.
This study's planned enrollment of 84 is above the median of 53 across 30 interventional studies indexed under Patella Fracture.
Browse Patella Fracture studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.
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.
Time frame: 1 year after injury
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)
Time frame: 1 year after injury
Range of Motion
Measurement of flexion and extension
Time frame: up to 24 months
TUG Test
Timed Up and Go test
Time frame: up to 24 months
Plan to share: No — No plan
Started Nov 2018 (actual). Primary completion is estimated for Dec 2022, 49 months after the start.
Of 18 interventional studies with no phase under Patella Fracture, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 136. This study's planned 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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