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临床试验/NCT06736639
NCT06736639已完成不适用

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

Second Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
final knee range of motion

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

final knee range of motion

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • operative time(6 months to 1.5 years after surgery)
  • functional recovery(6 months to 1.5 years after surgery)

研究者

发起方
Second Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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