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临床试验/NCT06602713
NCT06602713尚未招募不适用

Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
210
试验地点
2
主要终点
Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively

研究概览

简要总结

The stabilization surgical treatment by open Latarjet procedure is one of the reference treatments after anterior glenohumeral dislocation in athletes. This surgical technique allows low recurrence rates and high return to sport rates. Indeed, more than 90% of athletes return to sport after this type of surgery, but only 60% are able to resume the same activity as a preinjury level of performance. Therefore, adaptations in the postoperative management of athletes patients seem necessary. Isokinetic dynamometry is considered the gold standard to provide an objective assessment of muscle strength abilities, particularly in the clinical setting. Although rehabilitation exercises are prescribed early after the Latarjet procedure, muscle deconditioning occurs during the postoperative phase, limiting the abilities of the rotator cuff muscles to provide stability to the glenohumeral joint. Therefore, recovery of all components of strength, i.e. maximal strength, power, and strength endurance of the rotator cuff muscles appears crucial for the athletes to return to their sport at the pre-injury level. However, at present, the strength levels to be recovered remain to be defined.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient group:
  • Be aged between 18 and 45
  • Occurrence of the injury during the practice of a sporting activity
  • Post-traumatic anterior glenohumeral subluxation/dislocation
  • Contralateral shoulder with no history of injury
  • No other associated shoulder pathology
  • Patient scheduled for shoulder stabilizing surgery using an open Latarjet procedure performed by one of the surgeons at the Santy Orthopedic Center (Lyon)
  • No contraindication to isokinetic assessment
  • Patient having signed informed consent
  • Subject affiliated or beneficiary of a social security scheme
  • Healthy volunteers:
  • Be aged between 18 and 45
  • Regularly practice a sporting activity
  • No contraindication to isokinetic assessment
  • Person having signed informed consent
  • Subject affiliated or beneficiary of a social security scheme

排除标准

  • Patient group:
  • Contraindication from the sports clinician or surgeon
  • Have another pathology in the upper limbs.
  • Have constitutional hyperlaxity
  • Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Healthy volunteer group (athletes without a history of shoulder pathology):
  • Declare a history of pain/injury in the upper limbs in the last 6 months
  • Declare a history of orthopedic surgery in the upper limbs
  • Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

结局指标

主要结局

Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively

时间窗: 4 months

Bilateral muscle strength gap at 4 months postoperatively: * concentric internal rotators at 60°/s * concentric external rotators at 60°/s, * eccentric internal rotators at 60°/s, * eccentric external rotators at 60°/s, * concentric endurance internal rotators at 120°/s, * concentric endurance external rotators at 120°/s,

Return to same sport at pre-injury level assessed at 12 months post-operatively

时间窗: 12 months

questionnaire to the patient : what sport do you practice, which level?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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