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

Study Overview
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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.

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.

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

Conditions
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Surgery, Patella Fracture, Orthopedic Disorder

Intervention / Treatment
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* Procedure: Tension band fixation
* Procedure: Plate fixation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tension band fixation<br>Surgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice. | Procedure: Tension band fixation<br>* Fracture fixation of the patella fracture with tension band.<br>|
| Experimental: Plate fixation<br>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. | Procedure: Plate fixation<br>* Fracture fixation of the patella fracture with a plate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score - (KOOS5) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms. | One year following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score - (KOOS5) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms. | 3- and 6 months | 
| Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL. | The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms. | 3-, 6- and 12-months | 
| EQ-5D-5L questionnaire (5-level version) | General health will be assessed using EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death. | 3-, 6- and 12-months | 
| Pain intensity measured on a 10 cm VAS scale | Development in pain will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints no pain and maximal pain for the worst pain during the last 24 hours and resting pain. | 3-, 6- and 12-months | 
| PainDETECT questionnaire | Knee pain and neuropathic pain will be assessed using the PainDETECT questionnaire. The PainDETECT screening questionnaire uses a scoring method between 1-38. A total score of 1 indicates no symptoms, and 38 indicates major symptoms. | 3-, 6- and 12-months | 
| Bone union | Bone union, will be evaluated on standard AP and side X-rays of the fractured patella. The evaluation of bone union will be defined as: i) visible callus formation, diminished no visible fracture line and no pain from the fracture site at weight-bearing and at clinical examination. | 3-, 6- and 12-months | 
| Maximum isometric knee-extension strength | Maximum isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK) | 12-months | 
| Maximum isometric knee-flexion strength | Maximum isometric knee-flexion strength at 90 degrees knee flexion measured as Nm/kg body mass. Will be measured bilaterally by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK) | 12-months | 
| Knee range of motion | Knee range of motion. With the patient supine on an examination table the full range of passive motion in both knee joints will be measured using a standard goniometer. | 3-, 6- and 12-months | 
| Time to return to work | Measure the time from surgery to end of sick leave measured in days | 3-, 6- and 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patella fracture, surgery, Tension band, Plate