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临床试验/NCT04071912
NCT04071912已完成不适用

Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Change in Strength

研究概览

简要总结

Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.

challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.

详细描述

The investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction surgery since January 2016. The objective criterion were based on the international guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy).

The investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. The investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.

研究设计

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

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
  • Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months and 6-8 mnths after surgery respectively
  • Patient who received the information form

排除标准

  • Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
  • Cognitive or sensory impairment making it impossible to understand the information form
  • Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery

结局指标

主要结局

Change in Strength

时间窗: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines

Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

次要结局

  • Individual characteristics(ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines)
  • Injury characteristics(ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines)
  • Surgery characteristics(ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joffrey DRIGNY

Chief Resident PM&R and Sport departments MD, MSc

University Hospital, Caen

研究点 (1)

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