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临床试验/NCT02771548
NCT02771548招募中不适用

Biomechanical Analysis of Dynamic Tasks and Muscular Strength Following Anterior Cruciate Ligament Reconstruction

Dr Neil Welch ASCC1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Change in pain experienced

研究概览

简要总结

Background

Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an attempt to increase joint stability and facilitate athletes to return to sport (RTS). Although ACLR is considered a relatively successful procedure, dynamic control risk factors and strength and power deficits in the involved limb are still present after patients return to sport.

Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction cutting, have been shown to be common mechanisms of injury for the ACL in field sports . Returning to multidirectional sports requires a proficiency and efficiency of movement when carrying out these tasks. There is a lack of standardized, objective criteria to accurately assess an athlete's ability to safely RTS. Therefore, there is a need for research that simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular strength/power deficits that may explain poor outcomes following ACLR. This study aims to further investigate movement patterns, limb asymmetry and muscle strength deficit in patients post-surgery to identify risk factors for re-injury and criteria for RTS.

The purpose of this study was to:

  1. Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.
  2. To explore the association of those findings with those who re-injure, those who have persistent knee pain or with those who fail to return to sport.
  3. To compare the ACLR participants with age and gender matched healthy multidirectional athletes.

It is hypothesised that biomechanical analysis will identify clear risk factors for poor outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks will aid in the identification of athletes who are not yet ready to return to sport and will inform the clinician of what must be targeted in specific rehabilitation protocols before return to sport is considered.

Brief protocol

Participants will be recruited from patients who are scheduled to undergo anterior cruciate ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be recruited from local multidirectional teams. Participation will be voluntary and after obtaining informed consent patients will be asked to complete pre-operative questionnaires to ascertain injury information, and the function of their knee. During surgery the surgeon will fill out an intra-operative questionnaire. Items recorded will include graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.

Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while the healthy participants will be tested on one occasion. The 3D testing session will include capturing of jumping, landing, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the infrared cameras and tracked at 200 frames per second. Participants will make contact with a force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments. Participants will also perform a muscle strength test using equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be tested.

Participants will also be asked to fill out validated questionnaires to monitor self reported knee function, their confidence in their knee and also collect data on any continuing adverse symptoms such as locking, giving way, swelling or pain. Participants will also be asked if and when they return to sport. Questionnaires will be administered to participants at pre-op, 3, 6, 9, 12, 24 months, 5 and 10 years post operatively.

详细描述

3D Biomechanical testing involves the following progressive neuromuscular challenge tests:

  • Single leg countermovement jump - Vertical jump as high as possible off one leg.
  • Single leg drop jump- Hop from a 20cm height onto one leg and jump as high as possible with as little time spent on the ground
  • Double leg drop jump- Hop from a 30cm height onto one leg and jump as high as possible with as little time spent on the ground
  • Hurdle hop - Lateral hop over a 15cm hurdle followed by a hop back to the starting position and a hold for 2sec
  • Single Leg Hop for distance - maximal jump for horizontal distance on one leg while sticking the landing
  • Pre-planned change of direction cut - Sprint for 5 metres, make a 90 degree change of direction pre-determined by the tester and sprint for a further five meters to the finish
  • Indecision cut - Sprint for five meters then react to a light stimulus and make a 90 degree cut to the left or right for a further 1.5metres

Patient Registry

Patient data will be inputted into the Sports Surgery Clinic medical data management software. Captured data will include:

  1. Patient information - Date of Surgery, Surgeon, Side of ACLR, confirmative Magnetic Resonance Imaging
  2. Pre-Operative data collection

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
13 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Active participants
  • Anterior cruciate ligament reconstruction surgery in the Sports Surgery Clinic.
  • Over the age of 13 years

排除标准

  • Multiple orthopaedic injuries concurrently.
  • Surgery outside of Sports Surgery Clinic.

结局指标

主要结局

Change in pain experienced

时间窗: 6,9,12 and 24 months post operatively

Participants will be asked to rate their pain on a numerical rating scale, 0-10.

Injured operated knee- change in status

时间窗: 6,9,12 and 24 months post operatively

Participants are asked have they injured their operated knee.

Return to Performance- change in status

时间窗: 6,9,12 and 24 months post operatively

The Sports Surgery Clinic return to performance questionnaire asks whether the participant has returned to sport.

Injured their contralateral knee- change in status

时间窗: 6,9,12 and 24 months post operatively

Participants are asked have they injured their operated knee.

次要结局

  • Change in International Knee Documentation Committee (IKDC)(3, 6, 9, 12 and 24 months post surgery)
  • Change in Kinetic and kinematic composite score of the lower limb, pelvis and trunk(At 6 and 9 months post surgery)

研究者

发起方
Dr Neil Welch ASCC
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Neil Welch ASCC

Head of lab services and research

Sports Surgery Clinic, Santry, Dublin

研究点 (1)

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