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

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.

Study Overview

• Status: Recruiting
• Conditions: Patella Fracture
• Intervention / Treatment: Procedure: High-Strength Suture Modified Tension Band Fixation; Procedure: Screw-Cable Tension Band Fixation

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Anning Liu, M.Med. (candidate); Phone Number: +8615259370989; Email: jomt852@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fuzhou University Affiliated Provincial Hospital
      • Contact: Wei Xu, Dr; Phone Number: +8613959116868; Email: drxuwei@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suture Fixation (SF) Group; Patients receiving high-strength suture modified tension band fixation for patellar fracture.	Procedure: High-Strength Suture Modified Tension Band Fixation; Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.; Other Names: Suture Fixation (SF)
Screw-Cable Tension Band (SCTB) Group; Patients receiving traditional screw-cable tension band fixation for patellar fracture.	Procedure: Screw-Cable Tension Band Fixation; Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Healing Time	Time in weeks from surgery until radiographic evidence of fracture line blurring or disappearance on X-ray/CT.	Assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively or until healing confirmed
Radiographic Alignment Quality	Postoperative fracture reduction quality graded as good, satisfactory, or poor based on X-ray.	Immediately postoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively
Complication Rate	Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis).	From surgery to 12 months postoperatively
Reoperation Rate	Percentage of patients requiring any additional surgery related to the index fracture.	From surgery to 12 months postoperatively
Implant Removal Rate	Percentage of patients requiring removal of surgical implants.	From surgery to 12 months postoperatively
SF-36 (36-Item Short Form Health Survey) Score	36-Item Short Form Health Survey (SF-36) questionnaire assessing health-related quality of life. The SF-36 includes eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health); scores for each domain range from 0-100, with higher scores indicating better health status. The Physical Component Summary (PCS) and Mental Component Summary (MCS) will also be calculated and reported. Assessed at 12 months postoperatively.	12 months postoperatively
Surgical Time	Duration of the surgical procedure recorded in minutes from skin incision to closure.	Day of surgery
Intraoperative Blood Loss	Estimated volume of blood loss during surgery recorded in milliliters.	Day of surgery
Hospital Stay Duration	Number of days from the date of surgery to the date of hospital discharge.	From day of surgery to discharge
Quadriceps Muscle Strength (Manual Muscle Testing)	Quadriceps strength graded 0-5 using Manual Muscle Testing (MMT; 0 = no contraction, 5 = normal strength), compared with the contralateral side.	Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively
Patellar Height (Insall-Salvati Index)	Ratio of patellar tendon length to patellar length measured on lateral knee radiographs (normal range 0.8-1.2).	Assessed at 1 month, 3 months, 6 months, and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Fuzhou University Affiliated Provincial Hospital
• Investigators: Principal Investigator: Wei Xu, Dr, Fuzhou University Affiliated Provincial Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Knee Function; Prospective Cohort; Patellar Fracture; Tension Band Fixation; High-Strength Suture; Lysholm Score; VAS Pain Score
• Additional Relevant MeSH Terms: Knee Fractures; Wounds and Injuries; Fractures, Bone; Patella Fracture
• Other Study ID Numbers: K2025-10-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated study results and summary statistics will be made available through publications and conference presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No