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

Knee Ligament Injury Clinical Trial

— DIDT OSTEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875766
• Other study ID #: 2022-A00450-43
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: December 7, 2024

Study information

• Verified date: May 2023
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 7, 2024
• Est. primary completion date: April 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cruciate Ligament Rupture
• Knee Ligament Injury
• Osteopathia
• Rupture

Intervention

Other:
• Osteopathy
4 sessions of osteopathy after DIDT surgery
• Physiotherapy
Physiotherapy after DIDT surgery (reference treatment)

Locations

Country	Name	City	State
France	Hopital privé Jean Mermoz	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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