Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aging
  • Patella Fracture
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Data analysts will be blinded to the study treatment.Wherever possible, outcome assessors will be blinded to the study treatment.Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

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 ex...

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.

Tracking Information

NCT #
NCT03445819
Collaborators
Not Provided
Investigators
Principal Investigator: Aaron Nauth, MD, FRCS (C) Unity Health Toronto Principal Investigator: Jeremy Hall, MD, FRCS(C) Unity Health Toronto