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

NCT ID: NCT05875766

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2024-12-07

Brief Summary

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.

Conditions

Cruciate Ligament Rupture; Knee Ligament Injury; Osteopathia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient with osteopathy session

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

Group Type: EXPERIMENTAL

Osteopathy

Intervention Type: OTHER

4 sessions of osteopathy after DIDT surgery

Physiotherapy

Intervention Type: OTHER

Physiotherapy after DIDT surgery (reference treatment)

Patient without osteopathy session

Patients after their DIDT surgery have only physiotherapy

Group Type: PLACEBO_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Physiotherapy after DIDT surgery (reference treatment)

Interventions

Osteopathy

4 sessions of osteopathy after DIDT surgery

Intervention Type: OTHER

Physiotherapy

Physiotherapy after DIDT surgery (reference treatment)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital privé Jean Mermoz

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-François Oudet

Role: CONTACT

jf.oudet@ecten.eu

0683346567

Marie Hélène Barba

Role: CONTACT

mh.barba@ecten.eu

Facility Contacts

Nicolas CHOPIN, Dr

Role: primary

nicochop@free.fr

06 11 29 07 26

Other Identifiers

2022-A00450-43

Identifier Type: -

Identifier Source: org_study_id