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

NCT ID: NCT07248982

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suture Fixation (SF) Group

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

High-Strength Suture Modified Tension Band Fixation

Intervention Type: PROCEDURE

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

Screw-Cable Tension Band (SCTB) Group

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

Screw-Cable Tension Band Fixation

Intervention Type: PROCEDURE

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

Interventions

High-Strength Suture Modified Tension Band Fixation

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

Intervention Type: PROCEDURE

Screw-Cable Tension Band Fixation

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

Intervention Type: PROCEDURE

Other Intervention Names

Suture Fixation (SF)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuzhou University Affiliated Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anning Liu

Anning Liu, Emergency Medicine Graduate, Fujian medical university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Xu, Dr

Role: PRINCIPAL_INVESTIGATOR

Fuzhou University Affiliated Provincial Hospital

Locations

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Anning Liu, M.Med. (candidate)

Role: CONTACT

jomt852@163.com

+8615259370989

Facility Contacts

Wei Xu, Dr

Role: primary

drxuwei@sina.com

+8613959116868

References

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.

Reference Type: BACKGROUND

PMID: 35701245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17098238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9294799 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22183197 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33625743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37006729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38530504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38515618 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K2025-10-005

Identifier Type: -

Identifier Source: org_study_id