跳至主要内容
临床试验/CTRI/2024/07/070607
CTRI/2024/07/070607招募中不适用

Preoperative anthropometric correlation of peroneus longus graft in arthroscopic ACL reconstruction: A prospective study.

Dr Cyrus J Lalkaka1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2024年7月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
113
试验地点
1
主要终点
To potentially predict the peroneus longus graft dimensions using pre-operative anthropometric measurements in arthroscopic ACL reconstruction

研究概览

简要总结

Title of the project**:** Preoperative anthropometric correlation of peroneus longus graft in arthroscopic ACL reconstruction: A prospective study.

Type of Study: Single center prospective longitudinal descriptive study

Aims & objectives:

AIM: To potentially predict the peroneus longus graft dimensions using pre-operative anthropometric measurements in arthroscopic ACL reconstruction

OBJECTIVES: - To measure and document patient characteristics such as height, weight, BMI, leg length and calf circumference

  • To assess correlation between anthropometric measurements and peroneus longus graft measurements

  • To use preoperative anthropometric values to predict need for augmentation of graft

Departments involved: Department of Orthopaedics, Kasturba Medical College, Manipal

Study period: from July 2024 to May 2026

Sample size: 113

Calculated using Cochran’s sample size formula: n= z ² x p x (1-p) e² p=population size, e=margin of error, z=z value from z table

Calculated based on the study done by Rhatomy et al [14] Using prvalance= 8%, with 95% CI, and precision level of 5%, the calculation: (1.96)² x 0.08 x (0.92)/(0.05)² = Sample size = 113

Methodology:

The anthropometric measurements such as height, weight, body mass index, calf circumference and leg length (Medial joint line of knee to medial malleolus) will be preoperatively assessed. The length of peroneus longus will be measured intraoperatively immediately after harvesting. The doubled/ tripled/ quadrupled length and thickness of the peroneus longus graft will also be measured intraoperatively after preparing and tensioning the graft. The grafts will be taken by a single surgeon from the ipsilateral limb using a standard vertical supra malleolar incision at the distal end of the peroneus longus muscle and harvested in an identical fashion. The grafts will be measured intraoperatively by standard metal scales after removing muscle fibers and final trimmings of the tendon. The doubled, tripled or quadrupled graft will be passed through the Smith and Nephew sizing cylinder of 0.5mm increments till the minimum diameter that allows smooth passage of the graft which is taken as the thickness of the quadrupled graft. The femoral tunnel will be the same thickness as that of the graft. Both femoral and tibial fixation techniques will be identical in all procedures. The data will be compiled, scrutinized and evaluated to reach a conclusion regarding the relationship between peroneus longus graft dimensions and the patient’s anthropometric values.

All these procedures are part of standard of care. No additional procedures have been included in the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Arthroscopic ACL reconstruction using Peroneus longus graft
  • Age group 18 years and above
  • ACL injuries including multi ligamentous injuries.

排除标准

  • Pre-existing or associated pathology of the knee joint
  • Revision surgery
  • Previous surgeries around the knee
  • Patients on steroid or hormonal therapy
  • ACL avulsion fractures
  • Associated proximal tibia fractures
  • Deformity around the knee
  • Premature amputation of PL graft (muscle should be visible at the end of tendon after harvesting)
  • Diseases/syndromes which affect anthropometry eg.
  • Marfans syndrome, dwarfism, gigantism, etc.

结局指标

主要结局

To potentially predict the peroneus longus graft dimensions using pre-operative anthropometric measurements in arthroscopic ACL reconstruction

时间窗: Baseline

次要结局

  • Preoperative decision for requirement of augmentation of graft(Baseline)

研究者

发起方
Dr Cyrus J Lalkaka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Cyrus J Lalkaka

Kasturba Hospital, MAHE, Manipal

研究点 (1)

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