Prospective Cohort Study of High-Strength Suture Modified Tension Band Technique for the Treatment of Patellar Fractures
Conditions: Patella Fracture
Sponsor: Fuzhou University Affiliated Provincial Hospital

STUDY PROTOCOL AND STATISTICAL ANALYSIS
PLAN
Official Title: A Prospective Cohort Study of High-Strength Suture Modified Tension Band
Technique for the Treatment of Patellar Fractures
Institution: Fuzhou University Affiliated Provincial Hospital
Principal Investigator (PI): Dr. Wei Xu
Main Researcher: Anning Liu, M.Med. (candidate)
Ethics Approval Number: K2025-10-005
Version: Version 1.0 — January 2024
This protocol has been approved by the Ethics Committee of Fuzhou University Affiliated Provincial
Hospital (Approval No. K2025-10-005).

1. Study Objective
This study aims to evaluate the clinical efficacy and safety of the high-strength suture modified
tension band technique for patellar fracture fixation compared with the conventional screw-cable
tension band fixation. The primary outcomes include Lysholm knee function score, range of motion
(ROM), and pain score (VAS) at 12 months postoperatively.
2. Study Design
This is a prospective cohort study conducted at Fuzhou University Affiliated Provincial Hospital from
February 2024 to February 2026. Patients with AO/OTA 34-C1 or 34-C2 type patellar fractures will
be assigned into two groups based on surgical technique: the suture fixation (SF) group and the
screw-cable tension band (SCTB) group. Follow-up will be 12 months postoperatively.
3. Eligibility Criteria
Inclusion criteria include adults aged 18–55 years with confirmed patellar fractures (AO/OTA 34-C1
or 34-C2) and surgery within 2 weeks of injury. Exclusion criteria include pathological fractures,
prior patellar surgery, active infection, severe comorbidities, or inability to complete follow-up.
4. Outcome Measures
Primary outcomes: Lysholm Knee Score, Knee ROM, and VAS pain score at 12 months after
surgery. Secondary outcomes: fracture healing time, alignment quality, complication rate,
reoperation rate, implant removal rate, SF-36 score, and patient satisfaction.
5. Statistical Analysis
Data will be analyzed using IBM SPSS Statistics 27.0. Continuous variables will be expressed as
mean ± SD and compared using t-tests or Mann-Whitney U tests. Categorical variables will be
analyzed using Chi-square or Fisher’s exact test. Time-to-event data will be analyzed by
Kaplan-Meier method with log-rank test. Multivariate analyses may use linear or Cox regression.
Statistical significance is defined as p < 0.05 (two-sided).
6. Ethical Considerations
This study follows the Declaration of Helsinki and Good Clinical Practice guidelines. All participants
will provide written informed consent before enrollment. Patient confidentiality will be strictly
maintained. Any adverse events or serious adverse events will be reported to the Ethics Committee
within 24 hours.
7. Publication Plan
Results will be submitted to peer-reviewed journals in orthopedics or trauma surgery and presented
at scientific meetings. Data will be reported in aggregate form only.
Prepared by: Dr. Wei Xu and Anning Liu
Date: January 2024