About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
High-Strength Suture Modified Tension Band Fixation
Procedure/SurgeryUse of high-strength sutures for modified tension band fixation in patellar fracture surgery.
Screw-Cable Tension Band Fixation
Procedure/SurgeryUse of screws and cables for traditional modified tension band fixation in patellar fracture surgery.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Fracture Healing Time
Time in weeks from surgery until radiographic evidence of fracture line blurring or disappearance on X-ray/CT.
Radiographic Alignment Quality
Postoperative fracture reduction quality graded as good, satisfactory, or poor based on X-ray.
Complication Rate
Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis).
Reoperation Rate
Percentage of patients requiring any additional surgery related to the index fracture.
Sponsors and contacts
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