NCT04891549

Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures

TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Rasmus Elsøe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Patella Fracture
• Surgery
• Orthopedic Disorder

Interventions

Type	Name	Description
PROCEDURE	Tension band fixation	Fracture fixation of the patella fracture with tension band.
PROCEDURE	Plate fixation	Fracture fixation of the patella fracture with a plate.

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2021-05-18
• Last updated: 2026-01-15

Locations

6 sites across 1 country: Denmark