Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Patella Anatomical Locking Plate

    Device

    Patients 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

    Device

    Patients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patella Anatomical Locking Plate Group (Anterior Star Plate)Experimental treatment 1 intervention
Group B: Tension Band Wiring Group (Wiring)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
2

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.

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
3

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.

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

Secondary outcomes

1

Radiographic outcomes

Subjects' X-rays will be assessed for fracture healing progress.

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
2

Incidence of Complications

Complications such as fracture site infection, implant failure, and re-operation will be assessed and recorded

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
3

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).

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

Other outcomes

Sponsors and contacts

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