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

NCT06981039 | Recruiting DMC

• 1 other identifier: UW 24-025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patella Fracture

Keywords

trauma; knee injury; Tension Band Wiring; Patella fracture; Anatomical locking plate fixation

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Radiographic outcomes

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

• Incidence of Complications

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

• Subjective Implant Impingement Questionnaire

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

Study Arms (2)

Patella Anatomical Locking Plate Group (Anterior Star Plate)

EXPERIMENTAL

Fracture repair surgery using the patella anatomical locking plate

Device: Patella Anatomical Locking Plate

Tension Band Wiring Group (Wiring)

ACTIVE COMPARATOR

Fracture repair surgery with a tension band wire construct

Device: Tension Band Wiring

Interventions

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)

Patella Anatomical Locking Plate Group (Anterior Star Plate)

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.

Tension Band Wiring Group (Wiring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Patella Fracture; Wounds and Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Leg Injuries

Study Officials

• Christian Fang

  Dept of Orthopaedics and Traumatology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian FANG

CONTACT

+852 22554581; cfang@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Pragmatic, double-blind randomized controlled trial with 60 patients in two interventional arm

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 20, 2025
• Study Start: February 14, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of study completion
• Access Criteria: Additional information available upon reasonable request of principal investigator

Locations

HK (1)