RecruitingNCT07248982

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


Sponsor

Fuzhou University Affiliated Provincial Hospital

Enrollment

50 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria1

  • Age 18-55 years. 2.Radiographically confirmed patellar fracture (AO/OTA 34-C1 or 34-C2). 3.First-time patellar fracture surgery. 4.Time from injury to surgery ≤ 2 weeks. 5.Able to comply with follow-up and provide written informed consent. 6.Normal pre-injury knee function. 7.Able to tolerate surgery and agree to surgical treatment. 8.Intact cognitive function.

Exclusion Criteria3

  • Age <18 or >55 years. 2.Pathological fractures. 3.Prior patellar surgery or severe underlying patellofemoral disease. 4.Time from injury to surgery >2 weeks. 5.Concurrent active infection or severe medical conditions. 6.Severe neuropsychiatric disorders affecting follow-up compliance. 7.Postmenopausal women. 8.Inability to tolerate surgery or refusal of surgery. 9.Comorbid patellar dysplasia, rheumatoid arthritis, or other patellofemoral diseases.
  • Comorbid systemic or local infection at surgical site. 11.Comorbid severe lower limb or systemic injuries. 12.Pre-injury cognitive impairment, mental disorder, or independent walking disability.
  • Other conditions unsuitable for enrollment.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREHigh-Strength Suture Modified Tension Band Fixation

Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.

PROCEDUREScrew-Cable Tension Band Fixation

Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.


Locations(1)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07248982


Related Trials