NCT07248982

High-Strength Suture vs. Traditional Tension Band for Patellar Fractures

Prospective Cohort Study of High-Strength Suture Modified Tension Band Technique for the Treatment of Patellar Fractures

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fuzhou University Affiliated Provincial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study aims to evaluate the clinical efficacy of high-strength suture modified tension band fixation in treating patellar fractures and compare it with traditional screw-cable tension band fixation. Adult patients (18-55 years) with AO/OTA 34-C1 or 34-C2 patellar fractures will be enrolled and followed for 12 months. Primary outcomes include Lysholm knee function score, knee range of motion (ROM), and visual analog scale (VAS) pain score at 12 months post-surgery. Secondary outcomes include fracture healing time, radiographic alignment quality, complication rates, reoperation rates, implant removal rates, SF-36 health survey scores, and patient satisfaction. No additional biological samples will be collected; data will focus on clinical, radiographic, and follow-up information.

Detailed description

Patellar fractures account for approximately 1% of all fractures and are common in knee injuries. Traditional tension band fixation is widely used but associated with issues such as hardware migration, soft tissue irritation, and postoperative pain, impacting rehabilitation and quality of life. High-strength sutures offer improved biomechanical properties, flexibility, and reduced soft tissue damage. This study observes the clinical efficacy of high-strength suture modified tension band fixation compared to traditional methods through a prospective cohort design. Patients admitted to Fuzhou University Affiliated Provincial Hospital from February 2024 to February 2026 with patellar fractures undergoing surgery will be divided into two groups based on surgical method: Suture Fixation (SF) group and Screw-Cable Tension Band (SCTB) group. Follow-up will occur for 12 months, assessing outcomes such as postoperative VAS pain scores, Lysholm knee scores, ROM, SF-36 health surveys, surgical time, intraoperative blood loss, hospital stay, and complications (e.g., infection, fixation failure, nonunion). General data collected includes demographics (age, gender, height, weight, BMI), comorbidities (e.g., diabetes, hypertension, smoking), ASA classification, fracture details (side, type, displacement, mechanism, time from injury), and perioperative complications. Imaging assessments include fracture reduction quality (good, satisfactory, poor) via X-ray, healing time (weeks until fracture line blurs/disappears), and patellar height via Insall-Salvati index. Muscle strength (quadriceps via MMT, 0-5 grades) and patient satisfaction (1-5 scale) will also be evaluated. Adverse events (AEs) and serious adverse events (SAEs) will be recorded, reported to the ethics committee, and managed promptly. Statistical analysis will use IBM SPSS Statistics 27.0, with t-tests, Mann-Whitney U tests, chi-square/Fisher's exact tests, Kaplan-Meier curves, and regressions as appropriate. Intention-to-treat (ITT) analysis will be primary, with multiple imputation for missing data. The study is feasible given the hospital's patient volume and the principal investigator's experience. Ethical principles follow the Helsinki Declaration, with informed consent and privacy protection. Results will be published in academic journals and presented at conferences.

Conditions

• Patella Fracture

Interventions

Type	Name	Description
PROCEDURE	High-Strength Suture Modified Tension Band Fixation	Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.
PROCEDURE	Screw-Cable Tension Band Fixation	Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-28
• Completion: 2026-06-30
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: China