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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03445819
Other study ID # Patella RCT 2018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date December 31, 2023

Study information

Verified date June 2021
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Group A: Surgical 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
Other:
Group B: Conservative Treatment
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.

Locations

Country Name City State
Canada London Health Sciences Centre London Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other TUG Test Timed Up and Go test up to 24 months
Primary 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
Secondary 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
Secondary Range of Motion Measurement of flexion and extension up to 24 months
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