High-Strength Suture vs. Traditional Tension Band for Patellar Fractures

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorFuzhou University Affiliated Provincial Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • High-Strength Suture Modified Tension Band Fixation

    Procedure/Surgery

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

  • Screw-Cable Tension Band Fixation

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Suture Fixation (SF) Group1 intervention
Group B: Screw-Cable Tension Band (SCTB) Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months postoperatively
2

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.

Time frame
12 months postoperatively
3

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.

Time frame
12 months postoperatively

Secondary outcomes

1

Fracture Healing Time

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

Time frame
Assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively or until healing confirmed
2

Radiographic Alignment Quality

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

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

Complication Rate

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

Time frame
From surgery to 12 months postoperatively
4

Reoperation Rate

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

Time frame
From surgery to 12 months postoperatively

Other outcomes

Sponsors and contacts

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