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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Patella Fracture Surgery Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Tension band fixation

Surgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice.

Group Type ACTIVE_COMPARATOR

Tension band fixation

Intervention Type PROCEDURE

Fracture fixation of the patella fracture with tension band.

Plate fixation

Surgical fixation of the patella fracture utilizing the AO principles and a locking plate with the number of screws by surgeons choice. Additional fixation by surgeons choice.

Group Type EXPERIMENTAL

Plate fixation

Intervention Type PROCEDURE

Fracture fixation of the patella fracture with a plate.

Interventions

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Tension band fixation

Fracture fixation of the patella fracture with tension band.

Intervention Type PROCEDURE

Plate fixation

Fracture fixation of the patella fracture with a plate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Above 18 years of age
* Patella fracture suitable for surgically treatment, with both surgical methods
* AO classification 34-B, 34-C

Exclusion Criteria

* Open patella fracture above Gustillo grade 2
* Bilateral patella fracture
* Total knee replacement in the affected extremity
* Other fractures of the affected extremity within the previous 12 months.
* Other reasons for exclusion (unable to understand Danish, mentally unable to participate, etc).
* Prior ipsilateral patella fracture

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No