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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TUG Test | Timed Up and Go test | up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Nauth, MD, FRCS (C) | Unity Health Toronto | Principal Investigator |
| Jeremy Hall, MD, FRCS(C) | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | Canada | |||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625743 | Derived | 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. |
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| ID | Term |
|---|---|
| D000092462 | Patella Fracture |
| ID | Term |
|---|---|
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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Data analysts will be blinded to the study treatment.Wherever possible, outcome assessors will be blinded to the study treatment.
| Group B: Conservative Treatment | Other | Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery. |
|
Measurement of flexion and extension
| up to 24 months |
| Toronto |
| Ontario |
| Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |