Patella Fracture
Conditions
Keywords
Patellar Fracture, Tension Band Fixation, High-Strength Suture, Knee Function, Lysholm Score, VAS Pain Score, Prospective Cohort
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.
Interventions
PROCEDUREHigh-Strength Suture Modified Tension Band Fixation
Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.
PROCEDUREScrew-Cable Tension Band Fixation
Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.
Sponsors
Fuzhou University Affiliated Provincial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm Knee Score at 12 Months Postoperatively | 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. |
| Knee Range of Motion at 12 Months Postoperatively | 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. |
| Visual Analog Scale (VAS) Pain Score at 12 Months Postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate | From surgery to 12 months postoperatively | Percentage of patients requiring any additional surgery related to the index fracture. |
| Implant Removal Rate | From surgery to 12 months postoperatively | Percentage of patients requiring removal of surgical implants. |
| SF-36 (36-Item Short Form Health Survey) Score | 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. |
| Surgical Time | Day of surgery | Duration of the surgical procedure recorded in minutes from skin incision to closure. |
| Fracture Healing Time | 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. |
| Hospital Stay Duration | From day of surgery to discharge | Number of days from the date of surgery to the date of hospital discharge. |
| Quadriceps Muscle Strength (Manual Muscle Testing) | 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. |
| Patellar Height (Insall-Salvati Index) | 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). |
| Intraoperative Blood Loss | Day of surgery | Estimated volume of blood loss during surgery recorded in milliliters. |
| Radiographic Alignment Quality | 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. |
| Complication Rate | From surgery to 12 months postoperatively | Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis). |
Countries
China
Contacts
Primary ContactAnning Liu, M.Med. (candidate)
Outcome results
None listed