About this trial
This study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Diagnosed with an isolated closed injury, displaced, unstable fracture with displacement >2mm (AO/OTA Classification 34-B and C with surgical indication)
Able to give consent
Disqualifiers
History of previous knee surgery
Poly trauma,
Ongoing malignancy
Pre-existing severe knee osteoarthritis (>KL stage 4)
Trial design
Parallel
Treatments tested in this trial
Patella Anatomical Locking Plate
DevicePatients in the patella anatomical locking plate group will undergo internal fixation with an anterior locking plate and screw construct using the 2.7mm variable angle (VA) locking patella plating system (DePuy Synthes, Zuchwil, Switzerland)
Tension Band Wiring
DevicePatients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct.
Treatment groups
Trial outcomes
Primary outcomes
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Tegner Lysholm Knee Score
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Tegner Activity Scale
The Tegner Activity Scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
Secondary outcomes
Radiographic outcomes
Subjects' X-rays will be assessed for fracture healing progress.
Incidence of Complications
Complications such as fracture site infection, implant failure, and re-operation will be assessed and recorded
Subjective Implant Impingement Questionnaire
The questionnaire consists of 11 questions assessing the level of implant impingement reported by the patient, with a final score ranging from 0 (no impingement) to 20 (consistent impingement).
Sponsors and contacts
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