Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001, China
Location status: Recruiting
NCT Number: NCT07248982
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Observational
Fuzhou, Fujian, 350001, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.
Other names: Suture Fixation (SF)
Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.
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.
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.
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.
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.
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.
Time frame: From surgery to 12 months postoperatively
Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis).
Time frame: From surgery to 12 months postoperatively
Percentage of patients requiring any additional surgery related to the index fracture.
Time frame: From surgery to 12 months postoperatively
Percentage of patients requiring removal of surgical implants.
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.
Time frame: Day of surgery
Duration of the surgical procedure recorded in minutes from skin incision to closure.
Time frame: Day of surgery
Estimated volume of blood loss during surgery recorded in milliliters.
Time frame: From day of surgery to discharge
Number of days from the date of surgery to the date of hospital discharge.
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.
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).
Contact information is provided by the study sponsor or research team.
Fuzhou University Affiliated Provincial Hospital
Other
Prospective Cohort Study of High-Strength Suture Modified Tension Band Technique for the Treatment of Patellar Fractures
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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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