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NCT Number: NCT07248982

High-Strength Suture vs. Traditional Tension Band for 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Wei Xu, Dr

CONTACT

[email protected]

+8613959116868

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Strength Suture Modified Tension Band Fixation

Procedure

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

Other names: Suture Fixation (SF)

Screw-Cable Tension Band Fixation

Procedure

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

Primary outcomes

  1. Lysholm Knee Score at 12 Months Postoperatively

    Time frame: 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.

  2. Knee Range of Motion at 12 Months Postoperatively

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Fracture Healing Time

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

    Time in weeks from surgery until radiographic evidence of fracture line blurring or disappearance on X-ray/CT.

  2. Radiographic Alignment Quality

    Time frame: Immediately postoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively

    Postoperative fracture reduction quality graded as good, satisfactory, or poor based on X-ray.

  3. Complication Rate

    Time frame: From surgery to 12 months postoperatively

    Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis).

  4. Reoperation Rate

    Time frame: From surgery to 12 months postoperatively

    Percentage of patients requiring any additional surgery related to the index fracture.

  5. Implant Removal Rate

    Time frame: From surgery to 12 months postoperatively

    Percentage of patients requiring removal of surgical implants.

  6. SF-36 (36-Item Short Form Health Survey) Score

    Time frame: 12 months postoperatively

    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.

  7. Surgical Time

    Time frame: Day of surgery

    Duration of the surgical procedure recorded in minutes from skin incision to closure.

  8. Intraoperative Blood Loss

    Time frame: Day of surgery

    Estimated volume of blood loss during surgery recorded in milliliters.

  9. Hospital Stay Duration

    Time frame: From day of surgery to discharge

    Number of days from the date of surgery to the date of hospital discharge.

  10. Quadriceps Muscle Strength (Manual Muscle Testing)

    Time frame: Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively

    Quadriceps strength graded 0-5 using Manual Muscle Testing (MMT; 0 = no contraction, 5 = normal strength), compared with the contralateral side.

  11. Patellar Height (Insall-Salvati Index)

    Time frame: Assessed at 1 month, 3 months, 6 months, and 12 months postoperatively

    Ratio of patellar tendon length to patellar length measured on lateral knee radiographs (normal range 0.8-1.2).

Study contacts

Contact information is provided by the study sponsor or research team.

Anning Liu, M.Med. (candidate)

CONTACT

[email protected]

+8615259370989

Sponsors and collaborators

Lead sponsor

Fuzhou University Affiliated Provincial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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