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Recruiting NCT06981039

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

No phase Interventional Patella Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patella Anatomical Locking Plate, Tension Band Wiring.
Who it may be relevant to
Registry conditions: Patella Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The WASP Trial (Wiring Versus Anterior Star Plate): Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures: A Randomized Controlled Trial

Overview

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.

Detailed description

Patellar fractures are a common injury that can cause significant pain and disability. Conventional treatment options frequently include tension band wiring (TBW) with or without axial K-Wires or through cannulated screws. However, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures.

More recently, plate fixation has become increasingly more prevalent in the past decade. Initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. Biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to TBW. Its low profile construct and round edges may be more tolerable to patients and less prominent than TBW. Furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in TBW. This is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. This study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.

Interventions

  • Device Patella Anatomical Locking Plate
    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)
  • Device Tension Band Wiring
    Patients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct.

Primary outcome measures

  • Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
  • Tegner Lysholm Knee Score [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
  • Tegner Activity Scale [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
Secondary outcome measures (3)
  • Radiographic outcomes [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
  • Incidence of Complications [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
  • Subjective Implant Impingement Questionnaire [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • History of previous knee surgery
  • Poly trauma,
  • Ongoing malignancy
  • Pre-existing severe knee osteoarthritis (>KL stage 4)
  • Stroke
  • Other neurological conditions/injuries to the lower limb
  • Unfit for surgical anaesthesia
  • Non-ambulatory
  • Unable to consent or follow commands

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital, The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06981039 · UW 24-025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗