Clinical trial NCT06981039: Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patella Fracture
Keywords: trauma
knee injury
Tension Band Wiring
Patella fracture
Anatomical locking plate fixation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, double-blind randomized controlled trial with 60 patients in two interventional arm
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Tegner Lysholm Knee Score
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Tegner Activity Scale
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Secondary outcomes:
measure: Radiographic outcomes
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Incidence of Complications
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
measure: Subjective Implant Impingement Questionnaire
timeFrame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: Dept of Orthopaedics and Traumatology, Queen Mary Hospital
name: Christian Fang
role: PRINCIPAL_INVESTIGATOR
References: