Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06981039

The WASP Trial: Comparison of Patella Anatomical Locking Plate Versus Tension Band Wiring for Treating Unstable Patellar Fractures

Led by The University of Hong Kong · Updated on 2025-05-20

60

Participants Needed

1

Research Sites

25 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating and comparing two surgical methods for treating patellar fractures: the patella anatomical locking plate fixation and tension band wiring. This trial aims to assess the effectiveness and safety of these two approaches in patients with unstable patellar fractures. Patellar fractures can cause significant pain and disability, and while tension band wiring is a common treatment, it has drawbacks such as implant prominence and higher reoperation rates. The study involves two groups: one receiving fracture repair surgery using an anterior locking plate and screw construct called the patella anatomical locking plate, and the other undergoing open anatomical reduction with a tension band wire construct. The plate fixation uses a low-profile design that may reduce scarring and implant prominence compared to tension band wiring. This is a randomized controlled trial with double masking to compare these two surgical treatments. Participants will be followed with patient-reported functional outcome scores including the Knee Injury and Osteoarthritis Outcome Score (KOOS), Tegner Lysholm Knee Score, and Tegner Activity Scale at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. Additional assessments include radiographic imaging, complication rates, and implant impingement questionnaires at the same timepoints. The study is sponsored by The University of Hong Kong and aims to provide detailed safety and efficacy data over a one-year follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosed with an isolated closed injury, displaced, unstable patellar fracture with displacement greater than 2mm
  • Able to give consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Until hospital discharge

Participants undergo surgical fracture repair using either the patella anatomical locking plate or tension band wiring followed by immediate post-operative care.

1 surgery visit and initial post-operative care

Post-operative Follow-up

Duration - 12 months

Participants attend follow-up visits to assess healing, function, and implant status through patient-reported outcome scores and radiographic evaluations.

Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months post-surgery

Trial Site Locations

Total: 1 location

1

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

C

Christian FANG

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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