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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cruciate Ligament Rupture; Knee Ligament Injury; Osteopathia
• Intervention / Treatment: Other: Osteopathy; Other: Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-François Oudet; Phone Number: 0683346567; Email: jf.oudet@ecten.eu
• Study Contact Backup: Name: Marie Hélène Barba; Email: mh.barba@ecten.eu

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Nicolas CHOPIN, Dr; Phone Number: 06 11 29 07 26; Email: nicochop@free.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with osteopathy session; Patients after their DIDT surgery have 4 osteopathy sessions in addition to physiotherapy	Other: Osteopathy; 4 sessions of osteopathy after DIDT surgery; Other: Physiotherapy; Physiotherapy after DIDT surgery (reference treatment)
Placebo Comparator: Patient without osteopathy session; Patients after their DIDT surgery have only physiotherapy	Other: Physiotherapy; Physiotherapy after DIDT surgery (reference treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Estimated): April 7, 2024
• Study Completion (Estimated): December 7, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2022-A00450-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No