Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee (DIDT OSTEO)

Ramsay Générale de Santé

Status: Enrolling

Conditions: Cruciate Ligament Rupture; Knee Ligament Injury; Osteopathia

Treatments: Other: Physiotherapy; Other: Osteopathy

Study type: Interventional

Funder types: Other

Identifiers

NCT05875766

2022-A00450-43

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups, including a placebo group

Patient with osteopathy session

Experimental group

Description:

Patients after their DIDT surgery have 4 osteopathy sessions in addition to physiotherapy

Treatment:

Other: Osteopathy

Other: Physiotherapy

Patient without osteopathy session

Placebo Comparator group

Description:

Patients after their DIDT surgery have only physiotherapy

Treatment:

Other: Physiotherapy