Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Orthopedic Disorder
- Patella Fracture
- Surgery
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trialMasking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Due to the surgical nature of the study the surgeon can not be blinded. The outcome assessor, patients and care providers will be blinded with regards to the two treatment groups.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures. Primary objective The overall objective of the study is to compare the 1-year p...
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures. Primary objective The overall objective of the study is to compare the 1-year patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS5) after standard tension band fixation with locking plat fixation for patients with patella fractures. Secondary objectives Several other analyses are of interest and are planned but are not objectives of this study. Therefore, these analyses will, for the major part, hypothesis-generating. Analyses of this type include, but are not limited to harms, muscle atrophy, pain, general health, gait function, time to return to work and economical consequences between the two groups.
Tracking Information
- NCT #
- NCT04891549
- Collaborators
- Aarhus University Hospital
- Randers Regional Hospital
- Regional Hospital Hjoerring
- Regional Hospital Kolding
- Regional Hospital Viborg
- Investigators
- Study Chair: Rasmus Elsoe, MD, PhD Aalborg University Hospital, Denmark Principal Investigator: Peter Larsen, PT, PhD Aalborg University Hospital, Denmark
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