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

Primary Purpose

Cruciate Ligament Rupture, Knee Ligament Injury, Osteopathia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathy
Physiotherapy
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cruciate Ligament Rupture

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hopital privé Jean MermozRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patient with osteopathy session

Patient without osteopathy session

Arm Description

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

Patients after their DIDT surgery have only physiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Ramsay Générale de Santé
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1. Study Identification

Unique Protocol Identification Number
NCT05875766
Brief Title
Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee (DIDT OSTEO)
Acronym
DIDT OSTEO
Official Title
Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
April 7, 2024 (Anticipated)
Study Completion Date
December 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cruciate Ligament Rupture, Knee Ligament Injury, Osteopathia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with osteopathy session
Arm Type
Experimental
Arm Description
Patients after their DIDT surgery have 4 osteopathy sessions in addition to physiotherapy
Arm Title
Patient without osteopathy session
Arm Type
Placebo Comparator
Arm Description
Patients after their DIDT surgery have only physiotherapy
Intervention Type
Other
Intervention Name(s)
Osteopathy
Intervention Description
4 sessions of osteopathy after DIDT surgery
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy after DIDT surgery (reference treatment)
Primary Outcome Measure Information:
Title
assess the functionality of the knee
Description
Using International Knee Documentation Committee Subjective Knee Form (IKDC) measured 6 months postoperative and referring to the last weeks.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hopital privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas CHOPIN, Dr
Phone
06 11 29 07 26
Email
nicochop@free.fr

12. IPD Sharing Statement

Learn more about this trial

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

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