Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures
- Conditions
- Patella FractureSurgeryOrthopedic Disorder
- Interventions
- Procedure: Plate fixationProcedure: Tension band fixation
- Registration Number
- NCT04891549
- Lead Sponsor
- Rasmus Elsøe
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- Above 18 years of age
- Patella fracture suitable for surgically treatment, with both surgical methods
- AO classification 34-B, 34-C
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plate fixation 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. Tension band fixation Tension band fixation Surgical fixation of the patella fracture utilizing the AO principles using K-wires, screws, cerclage and sutures by surgeons choice.
- Primary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score - (KOOS5) One year following treatment 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.
- Secondary Outcome Measures
Name Time Method EQ-5D-5L questionnaire (5-level version) 3-, 6- and 12-months 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.
Pain intensity measured on a 10 cm VAS scale 3-, 6- and 12-months 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.
Bone union 3-, 6- and 12-months 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.
Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL. 3-, 6- and 12-months 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.
Knee Injury and Osteoarthritis Outcome Score - (KOOS5) 3- and 6 months 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.
"PainDETECT" questionnaire 3-, 6- and 12-months 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.
Maximum isometric knee-extension strength 12-months 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)
Maximum isometric knee-flexion strength 12-months 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)
Knee range of motion 3-, 6- and 12-months 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.
Time to return to work 3-, 6- and 12-months Measure the time from surgery to end of sick leave measured in days
Trial Locations
- Locations (6)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Regional Hospital Randers
🇩🇰Randers, Denmark
Regional Hospital Viborg
🇩🇰Viborg, Denmark
Regional Hospital Hjoerring
🇩🇰Hjørring, Denmark
Regional Hospital Kolding
🇩🇰Kolding, Denmark