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

NCT05875766 | Unknown

• 1 other identifier: 2022-A00450-43
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• assess the functionality of the knee

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

  6 months

Study Arms (2)

Patient with osteopathy session

EXPERIMENTAL

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

Other: Osteopathy; Other: Physiotherapy

Patient without osteopathy session

PLACEBO COMPARATOR

Patients after their DIDT surgery have only physiotherapy

Other: Physiotherapy

Interventions

Osteopathy OTHER

4 sessions of osteopathy after DIDT surgery

Patient with osteopathy session

Physiotherapy OTHER

Physiotherapy after DIDT surgery (reference treatment)

Patient with osteopathy session; Patient without osteopathy session

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hopital privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Bone Diseases

Interventions

Osteopathic Physicians; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services; Therapeutics; Rehabilitation

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: April 7, 2023
• Primary Completion: April 7, 2024
• Study Completion: December 7, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

FR (1)