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

Not Applicable

Recruiting

• Conditions: Patella Fracture

• Registration Number: NCT06981039
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2024-02-14
• Status Verified: 2025-04
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-01-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	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.
Tegner Activity Scale	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	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.
Tegner Lysholm Knee Score	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic outcomes	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	Subjects' X-rays will be assessed for fracture healing progress.
Incidence of Complications	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	Complications such as fracture site infection, implant failure, and re-operation will be assessed and recorded
Subjective Implant Impingement Questionnaire	At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months	The questionnaire consists of 11 questions assessing the level of implant impingement reported by the patient, with a final score ranging from 0 (no impingement) to 20 (consistent impingement).

Trial Locations

Locations (1)

Queen Mary Hospital, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong