High-strength suture versus traditional tension band to fix a broken kneecap

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

This project will see if using a high-strength suture tension band instead of the traditional screw-cable tension band reduces pain and improves knee function in adults (18–55) with certain displaced patellar fractures (AO/OTA 34-C1 or 34-C2).

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Fuzhou University Affiliated Provincial Hospital (other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07248982 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort study enrolling adults 18–55 with specified displaced patellar fractures who undergo surgical fixation at Fuzhou University Affiliated Provincial Hospital. Patients will be grouped by the surgical method they receive (high-strength suture modified tension band versus screw-cable tension band) and followed for 12 months. Primary outcomes at 12 months include Lysholm knee function score, knee range of motion, and VAS pain score; secondary outcomes include time to radiographic healing, alignment quality, complications, reoperations, implant removal, SF-36, and patient satisfaction. Clinical, demographic, perioperative, and radiographic data will be collected without additional biological sampling.

Who should consider this trial

Good fit: Adults aged 18–55 with a first-time, radiographically confirmed AO/OTA 34-C1 or 34-C2 patellar fracture who can have surgery within two weeks and commit to 12 months of follow-up are the ideal candidates.

Not a fit: Patients outside the 18–55 age range, with pathological fractures, prior patellar surgery, severe patellofemoral disease, active infection, inability to tolerate surgery, or who cannot comply with follow-up are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the suture-based technique could reduce implant-related pain and irritation, lower implant removal and reoperation rates, and speed recovery of knee function.

How similar studies have performed: Prior biomechanical studies and small clinical series suggest high-strength sutures can reduce hardware irritation and perform well mechanically, but large prospective comparative data are limited.

Eligibility criteria

Inclusion Criteria:

* 1.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 Criteria:

* 1.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.

  10.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.

  13.Other conditions unsuitable for enrollment.

Where this trial is running

Fuzhou, Fujian

• Fuzhou University Affiliated Provincial Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Wei Xu, Dr — Fuzhou University Affiliated Provincial Hospital
• Study coordinator: Anning Liu, M.Med. (candidate)

Conditions: Patella Fracture, Patellar Fracture, Tension Band Fixation, High-Strength Suture, Knee Function, Lysholm Score, VAS Pain Score, Prospective Cohort