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RecruitingNCT05875766DIDT OSTEOUpdated May 25, 2023

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

An interventional study of Osteopathy and Physiotherapy in Cruciate Ligament Rupture, Knee Ligament Injury and Osteopathia, sponsored by Ramsay Générale de Santé. Recruiting at 1 site in France. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cruciate Ligament Rupture
  • Knee Ligament Injury
  • Osteopathia

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03

In context

Bone Diseases

177 studies on the registry are indexed under Bone Diseases; 38 are open to participants now.

This study's planned enrollment of 94 is above the median of 53 across 113 interventional studies indexed under Bone Diseases.

Browse Bone Diseases studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient, male or female, aged 18 to 35 inclusive
  • Patient with a 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

Exclusion Criteria:

  • Patient with damage to another structure of the knee, other than meniscal lesions.
  • Patient with a 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    Patient with osteopathy session

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

    Other: Osteopathy · Other: Physiotherapy

  • Placebo comparator
    Patient without osteopathy session

    Patients after their DIDT surgery have only physiotherapy

    Other: Physiotherapy

Interventions

  • OtherOsteopathy

    4 sessions of osteopathy after DIDT surgery

  • OtherPhysiotherapy

    Physiotherapy after DIDT surgery (reference treatment)

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Apr 2024, 12 months after the start.

Of 25 interventional studies with no phase under Bone Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 54. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
May 25, 2023
StartActual
Apr 7, 2023
Primary completionEst.
Apr 7, 2024
CompletionEst.
Dec 7, 2024
Last update
May 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05875766
Lead sponsor
Ramsay Générale de Santé
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Apr 7, 2023
Primary completion
Apr 7, 2024 (estimated)
Completion
Dec 7, 2024 (estimated)
Last update
May 25, 2023

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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