Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite Element Analysis Combined with a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment

Completed

• Conditions: Inferior Patellar Fracture; Fracture Maps; Finite Element Analysis

• Registration Number: NCT06736639
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief Summary

The goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (IPPF): anchor suture with patellar cerclage and Kirschner-wire tension band combined with patellar cerclage. The study involves patients with IPPF, focusing on fracture patterns and treatment outcomes.

1. Undergo retrospective analysis of fracture patterns using fracture mapping.

2. Participate in biomechanical analysis via finite element modeling of both treatment methods.

3. Be part of a clinical comparison between two surgical treatments based on operative time, postoperative complications, and functional outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

(1) diagnosis of IPPF confirmed by X-ray or CT, and (2) patients aged between 18 and 70 years.

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Exclusion Criteria

(1) concomitant fractures of other parts of the knee, (2) open fractures, and (3) pathological fractures.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
final knee range of motion	6 months to 1.5 years after surgery	The final knee range of motion is assessed to evaluate the functional recovery of patients following surgical treatment for inferior pole patellar fractures (IPPF). This measure includes the degree of flexion and extension achieved during follow-up, as documented through physical examination and patient self-reports. The range of motion is compared between the two intervention groups to determine the effectiveness of each treatment method in restoring knee functionality and mobility. Outcomes are measured and analyzed based on clinical standards and benchmarks for knee rehabilitation.
incidence of secondary surgery	6 months to 1.5 years after surgery	The incidence of secondary surgery is defined as the number of patients who require an additional surgical procedure related to the treatment of inferior pole patellar fractures (IPPF) within the follow-up period. This includes procedures to address complications such as hardware irritation, infection, nonunion, malunion, or mechanical failure of the initial fixation. The data will be compared between the two intervention groups to evaluate the durability and long-term effectiveness of each surgical technique. This measure provides critical insights into the need for re-intervention and overall treatment success.
postoperative complications	6 months to 1.5 years after surgery	Postoperative complications include any adverse events or clinical issues occurring as a result of the surgical treatment for inferior pole patellar fractures (IPPF) within the follow-up period. These complications may include, but are not limited to, hardware irritation, infection, wound dehiscence, delayed union, nonunion, or malunion. Data will be collected from medical records and follow-up visits to identify the frequency and types of complications in each intervention group. The results will be analyzed to compare the safety profiles of the anchor suture with titanium cable cerclage and the Kirschner wire tension band with cerclage cable techniques. This outcome is critical for assessing the overall safety and effectiveness of each surgical approach.

Secondary Outcome Measures

Name	Time	Method
operative time	6 months to 1.5 years after surgery	Operative time is defined as the total duration of the surgical procedure, measured from the initial incision to the completion of wound closure. This outcome measure evaluates the efficiency of the surgical intervention and provides insights into the complexity and technical demands of each technique. Operative time is compared between the two groups (anchor suture with titanium cable cerclage vs. Kirschner wire tension band with cerclage cable) to assess any significant differences in surgical duration. This metric is particularly relevant in evaluating the practicality and feasibility of each intervention in clinical practice.
functional recovery	6 months to 1.5 years after surgery	Functional recovery is evaluated using validated scoring systems, such as the Bostman score, to assess the restoration of knee function following surgical treatment for inferior pole patellar fractures (IPPF). This measure includes parameters such as pain levels, range of motion, ability to perform daily activities, and overall patient satisfaction. Data will be collected during follow-up visits to determine the extent of functional improvement and to compare outcomes between the two intervention groups (anchor suture with titanium cable cerclage vs. Kirschner wire tension band with cerclage cable). This outcome provides critical insights into the effectiveness of each surgical technique in achieving optimal rehabilitation and long-term knee function.

Trial Locations

Locations (1)

The medical record system and imaging system of the Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China