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

NCT ID: NCT06981039

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patella Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, double-blind randomized controlled trial with 60 patients in two interventional arm
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants are randomly assigned to either one of the interventional arms and will not be informed of the randomization result.

A blinded reviewer will assess the radiographs, surgical quality, and clinical outcomes postoperatively and during study follow-ups.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patella Anatomical Locking Plate Group (Anterior Star Plate)

Fracture repair surgery using the patella anatomical locking plate

Group Type EXPERIMENTAL

Patella Anatomical Locking Plate

Intervention Type 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 Group (Wiring)

Fracture repair surgery with a tension band wire construct

Group Type ACTIVE_COMPARATOR

Tension Band Wiring

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Christian Xinshuo Fang

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Fang

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthopaedics and Traumatology, Queen Mary Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Mary Hospital, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christian FANG

Role: CONTACT

+852 22554581

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christian FANG

Role: primary

+852 22554581

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UW 24-025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Weight Bearing in Distal Femur Fractures
NCT06806839 NOT_YET_RECRUITING NA