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临床试验/NCT07538245
NCT07538245已完成不适用

Prediction of Quadrupled Rectus Femoris Graft Diameter Using Anthropometric and Tendon Parameters

Samsun University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2026年4月18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
105
试验地点
1
主要终点
Quadrupled rectus femoris graft diameter (mm)

研究概览

简要总结

This study aims to develop and validate a predictive model for estimating the diameter of a quadrupled rectus femoris tendon graft used in anterior cruciate ligament (ACL) reconstruction. By analyzing patient anthropometric characteristics and intraoperative tendon measurements, we aim to identify reliable predictors of graft size to improve preoperative planning and surgical decision-making.

详细描述

Graft diameter is a critical determinant of success in anterior cruciate ligament (ACL) reconstruction. Smaller graft sizes have been associated with increased failure rates. While predictive models exist for hamstring tendon grafts, no validated model currently exists for rectus femoris tendon grafts.

This study seeks to develop a predictive algorithm for estimating the diameter of a quadrupled rectus femoris graft using patient-specific anthropometric and tendon-related variables.

Data will be collected prospectively (or retrospectively if applicable) from patients undergoing ACL reconstruction using rectus femoris tendon autografts. Statistical modeling, including multivariate regression analysis, will be used to identify independent predictors and generate a predictive formula.

The study also aims to evaluate the diagnostic performance of the model in identifying clinically adequate graft sizes (≥8 mm or ≥9 mm).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients aged 18 years or older
  • Undergoing primary ACL reconstruction
  • Use of rectus femoris tendon autograft
  • Availability of complete anthropometric and intraoperative data

排除标准

  • Incomplete dataset

研究组 & 干预措施

Standard ACL Reconstruction

Patients undergoing primary ACL reconstruction with rectus femoris tendon autograft will be prospectively enrolled. The study is observational, and no additional intervention will be performed. Patient-specific anthropometric measurements and intraoperative graft parameters will be collected to develop and validate a predictive model for graft diameter.

结局指标

主要结局

Quadrupled rectus femoris graft diameter (mm)

时间窗: Baseline

Measured intraoperatively using standard graft sizing tubes

次要结局

  • Prediction accuracy (difference between predicted and actual graft diameter)(Baseline)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Emin Okutan

MD

Samsun University

研究点 (1)

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