Cruciate Ligament RuptureDIDT OSTEONCT05875766
Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee (DIDT OSTEO)
A study testing Osteopathy and Physiotherapy in people with Cruciate Ligament Rupture and Knee Ligament Injury, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Cruciate Ligament Rupture, Knee Ligament Injury, Osteopathia
- What is being tested?
- Osteopathy and Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2023to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Marie Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hopital privé Jean Mermoz
Lyon, 69008
Nicolas CHOPIN, Dr, 06 11 29 07 26, nicochop@free.fr
About this study
Official title: 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.
- Conditions
- Cruciate Ligament Rupture, Knee Ligament Injury, Osteopathia
- Being tested
- Osteopathy, Physiotherapy
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathyOther
4 sessions of osteopathy after DIDT surgery
PhysiotherapyOther
Physiotherapy after DIDT surgery (reference treatment)
| Study group | Role | What they receive |
|---|---|---|
| Patient with osteopathy session | Experimental | Patients after their DIDT surgery have 4 osteopathy sessions in addition to physiotherapy Receives: Other: Osteopathy; Other: Physiotherapy |
| Patient without osteopathy session | Placebo comparator | Patients after their DIDT surgery have only physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start7 Apr 2023
- Primary completion7 Apr 2024 (estimated)
- Study completion7 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875766
- Sponsor's protocol ID
- 2022-A00450-43
- Acronym
- DIDT OSTEO
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee
- ClinicalTrials.gov ID
- NCT05875766
- Acronym / sponsor ID
- DIDT OSTEO / 2022-A00450-43
- Conditions
- Cruciate Ligament Rupture, Knee Ligament Injury, Osteopathia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 7 Apr 2024 (estimated)
- Study completion
- 7 Dec 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with osteopathy session | Experimental | Other: Osteopathy, Other: PhysiotherapyPatients after their DIDT surgery have 4 osteopathy sessions in addition to physiotherapy |
| Patient without osteopathy session | Placebo comparator | Other: PhysiotherapyPatients after their DIDT surgery have only physiotherapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathy4 sessions of osteopathy after DIDT surgery | Other | Patient with osteopathy session |
| PhysiotherapyPhysiotherapy after DIDT surgery (reference treatment) | Other | Patient with osteopathy session, Patient without osteopathy session |
Primary outcome
assess the functionality of the knee
Time frame: 6 months
Using International Knee Documentation Committee Subjective Knee Form (IKDC) measured 6 months postoperative and referring to the last weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Related trials for Cruciate Ligament Rupture
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathy and Physiotherapy in people with Cruciate Ligament Rupture and Knee Ligament Injury, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the functionality of the knee (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.