跳至主要内容
临床试验/NCT05875766
NCT05875766招募中不适用

Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2023年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
94
试验地点
2
主要终点
assess the functionality of the knee

研究概览

简要总结

The antero-external cruciate ligament (ACL) is the ligament located inside the knee, which allows the rotation of the knee by stabilizing the femur and the tibia. Rupture of the ACL is common during the practice of certain so-called "pivot" sports, whether contact or not. It is manifested by acute pain or instability of the knee, following a crack during a twist and/or a blockage of the joint. The diagnosis will be confirmed by a clinical examination and X-rays to eliminate any fracture or tearing and by MRI to visualize the ligament rupture and the associated lesions, in particular a lesion of the meniscus.

Treatment is required because the ruptured ligament does not heal on its own and the rupture of the ligament may eventually promote the appearance of osteoarthritis. Two types of treatment can be considered, rehabilitation or surgery, depending on the patient's age and motivation to resume sports. There are several surgical techniques, the most common is to reconstruct the ruptured ligament by arthroscopy using a graft taken from the tendons of the Internal Rectus and Demi muscles tendinous (DIDT). Rehabilitation by physiotherapy is often started preoperatively and immediately after the operation, as soon as you wake up, to find a functional and painless knee. Functional recovery often depends on patient motivation.

The main objective is to show that osteopathic care in addition to physiotherapy rehabilitation improves knee functionality in patients 6 months after reconstruction of the ACL by DIDT.

研究设计

研究类型
Interventional
分配方式
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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient, male or female, aged 18 to 35 inclusive
  • Patient with a BMI between 18.5 and 30 kg/m² (limits included).
  • Patient presenting with a total rupture of the unilateral anterior cruciate ligament (ACL).
  • Candidate patient for reconstruction of the ACL with the DIDT method.
  • Affiliated patient or beneficiary of a social security scheme.
  • Patient having been informed and having given their free consent, enlightened and written.

排除标准

  • Patient with damage to another structure of the knee, other than meniscal lesions.
  • Patient with a contraindication to osteopathic intervention.
  • Patient for whom a method other than DIDT has been proposed.
  • Patient with iterative rupture of the ACL.
  • Patient having undergone ligamentoplasty of the contralateral knee
  • Patient participating in another research.
  • Patient in period of exclusion from another research still in progress at the time of inclusion.
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
  • Pregnant, breastfeeding or parturient women.
  • Patient hospitalized without consent.

结局指标

主要结局

assess the functionality of the knee

时间窗: 6 months

Using International Knee Documentation Committee Subjective Knee Form (IKDC) measured 6 months postoperative and referring to the last weeks.

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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