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

NCT07248982 | Recruiting

• 1 other identifier: K2025-10-005
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patella Fracture

Keywords

Patellar Fracture; Tension Band Fixation; High-Strength Suture; Knee Function; Lysholm Score; VAS Pain Score; Prospective Cohort

Outcome Measures

Primary Outcomes (3)

• Lysholm Knee Score at 12 Months Postoperatively

  Lysholm knee scoring scale (0-100 points; 95-100 = excellent, 84-94 = good, 65-83 = fair, \<65 = poor; higher scores indicate better knee function). Assessed at baseline (pre-injury recalled), 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.

  12 months postoperatively

• Knee Range of Motion at 12 Months Postoperatively

  Active knee flexion and extension range of motion measured in degrees with a goniometer (higher values indicate better function). Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.

  12 months postoperatively

• Visual Analog Scale (VAS) Pain Score at 12 Months Postoperatively

  Visual Analog Scale for pain (0-10 points; 0 = no pain, 10 = worst imaginable pain; higher scores indicate more severe pain). Assessed preoperatively and at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.

  12 months postoperatively

Secondary Outcomes (11)

• Fracture Healing Time

  Assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively or until healing confirmed

• Radiographic Alignment Quality

  Immediately postoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively

• Complication Rate

  From surgery to 12 months postoperatively

• Reoperation Rate

  From surgery to 12 months postoperatively

• Implant Removal Rate

  From surgery to 12 months postoperatively

Study Arms (2)

Suture Fixation (SF) Group

Patients receiving high-strength suture modified tension band fixation for patellar fracture.

Procedure: High-Strength Suture Modified Tension Band Fixation

Screw-Cable Tension Band (SCTB) Group

Patients receiving traditional screw-cable tension band fixation for patellar fracture.

Procedure: Screw-Cable Tension Band Fixation

Interventions

High-Strength Suture Modified Tension Band Fixation PROCEDURE

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

Also known as: Suture Fixation (SF)

Suture Fixation (SF) Group

Screw-Cable Tension Band Fixation PROCEDURE

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

Screw-Cable Tension Band (SCTB) Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with patellar fractures seeking surgical treatment at Fuzhou University Affiliated Provincial Hospital, meeting inclusion criteria, and grouped based on surgical technique received.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou University Affiliated Provincial Hospital: lead

Study Sites (1)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (8)

• Adjal J, Haugaard A, Vesterby L, Ibrahim HM, Sert K, Thomsen MG, Tengberg PT, Ban I, Ohrt-Nissen S. Suture tension band fixation vs. metallic tension band wiring for patella fractures - A biomechanical study on 19 human cadaveric patellae. Injury. 2022 Aug;53(8):2749-2753. doi: 10.1016/j.injury.2022.05.015. Epub 2022 May 26.

  PMID: 35701245 BACKGROUND

• Hughes SC, Stott PM, Hearnden AJ, Ripley LG. A new and effective tension-band braided polyester suture technique for transverse patellar fracture fixation. Injury. 2007 Feb;38(2):212-22. doi: 10.1016/j.injury.2006.07.013. Epub 2006 Nov 13.

  PMID: 17098238 BACKGROUND

• Carpenter JE, Kasman RA, Patel N, Lee ML, Goldstein SA. Biomechanical evaluation of current patella fracture fixation techniques. J Orthop Trauma. 1997 Jul;11(5):351-6. doi: 10.1097/00005131-199707000-00009.

  PMID: 9294799 BACKGROUND

• LeBrun CT, Langford JR, Sagi HC. Functional outcomes after operatively treated patella fractures. J Orthop Trauma. 2012 Jul;26(7):422-6. doi: 10.1097/BOT.0b013e318228c1a1.

  PMID: 22183197 BACKGROUND

• Sayum Filho J, Lenza M, Tamaoki MJ, Matsunaga FT, Belloti JC. Interventions for treating fractures of the patella in adults. Cochrane Database Syst Rev. 2021 Feb 24;2(2):CD009651. doi: 10.1002/14651858.CD009651.pub3.

  PMID: 33625743 BACKGROUND

• Huang L, Li X, Ye L, Li S. Closed Reduction and High-Strength Sutures for Transverse Patella Fractures: A Retrospective Analysis. Indian J Orthop. 2023 Feb 27;57(4):571-576. doi: 10.1007/s43465-023-00843-4. eCollection 2023 Apr.

  PMID: 37006729 BACKGROUND

• Giuseppe R, Michele R, Luca F, Michele G, Giuseppe G, Valentina M, Giustra F, Bosco F, Camarda L. Nonmetallic tension band fixation is a viable and low-complication surgical technique in patellar fractures: a five-year retrospective study. Eur J Orthop Surg Traumatol. 2024 May;34(4):2065-2071. doi: 10.1007/s00590-024-03887-w. Epub 2024 Mar 26.

  PMID: 38530504 BACKGROUND

• Xiang F, Xiao Y, Li D, Ma W, Chen Y, Yang Y. Tension band high-strength suture combined with absorbable cannulated screws for treating transverse patellar fractures: finite element analysis and clinical study. Front Bioeng Biotechnol. 2024 Mar 7;12:1340482. doi: 10.3389/fbioe.2024.1340482. eCollection 2024.

  PMID: 38515618 BACKGROUND

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Wei Xu, Dr

  Fuzhou University Affiliated Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anning Liu, M.Med. (candidate)

CONTACT

+8615259370989; jomt852@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anning Liu, Emergency Medicine Graduate, Fujian medical university

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: February 1, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)