Clinical trial NCT03445819: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Patella Fracture
Aging
Keywords: Patella Fracture, elderly
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year after injury
Secondary outcomes:
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 1 year after injury
measure: Range of Motion
timeFrame: up to 24 months
Other outcomes:
measure: TUG Test
timeFrame: up to 24 months
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Aaron Nauth, MD, FRCS (C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Jeremy Hall, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
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.