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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06736639
Enrollment
57
Registered
2024-12-17
Start date
2024-08-01
Completion date
2024-09-02
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Finite Element Analysis, Fracture Maps, Inferior Patellar Fracture

Keywords

Inferior Patellar Fracture, Fracture Maps, Finite Element Analysis, Retrospective Study

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.

Interventions

PROCEDUREAnchor Suture with Titanium Cable Cerclage

This intervention involves the use of \*\*anchor suture fixation combined with titanium cable cerclage\*\* for the treatment of inferior pole patellar fractures (IPPF). The anchor suture provides stable fixation of fracture fragments by anchoring directly into the bone, while the titanium cable cerclage offers additional reinforcement around the patella to enhance stability and minimize fragment displacement. This method is specifically designed to address the limitations of traditional Kirschner-wire tension band techniques, such as hardware irritation and infection, by using biocompatible and low-profile materials.

PROCEDUREKirschner wire tension band + cerclage cable

This intervention uses \*\*Kirschner wire tension band combined with cerclage cable\*\* to treat inferior pole patellar fractures (IPPF). The Kirschner wires are positioned across the fracture site to form a tension band, which transforms tensile forces into compressive forces, promoting fracture stability. The cerclage cable is added to reinforce the fixation by encircling the patella, providing additional stability to comminuted or complex fractures.

Sponsors

Second Affiliated Hospital of Soochow University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
final knee range of motion6 months to 1.5 years after surgeryThe 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 surgery6 months to 1.5 years after surgeryThe 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 complications6 months to 1.5 years after surgeryPostoperative 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

MeasureTime frameDescription
operative time6 months to 1.5 years after surgeryOperative 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 recovery6 months to 1.5 years after surgeryFunctional 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026