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Knee surgery device shows promising 2-Year results in small study

NCT ID NCT06990100

Disease control Sponsor: SACIMEX Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a device called ENDOPACK® DT4-EBMCA works for repairing a torn anterior cruciate ligament (ACL) in the knee. Researchers followed 36 patients for 2 years after surgery to measure knee function and check for complications. The goal was to see if the device is safe and effective in everyday medical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Oct 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient implanted with DT4-EBMCA in Médipôle Garonne for a total or partial rupture of the anterior cruciate ligaments * Patient having answer to IKDC and KOOS pre-operative * Patient having received information and signed informed consent Exclusion Criteria: * Patients who refuse to participate * Patients unable to understand questionnaires * Patients who, at the time of surgery, present the contraindications and Factors likely to jeopardize the success of the implant contained in the IFU : * Acute or chronic, local or systemic infections; * Severe muscular, neurological or vascular impairments affecting the extremity concerned; * Bone destruction or poor bone quality that may affect device stability; * Any concomitant condition that may affect device function; * Patients with sensitivity to device material that may cause allergic reactions. * Severe osteoporosis; * Significant deformity, congenital dislocation; * Local bone tumours; * Systemic or metabolic disorders; * Infectious diseases; * Substance abuse and/or tendencies to abuse drugs or medication; * Obesity; * Unsupervised intense physical activity.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acl rupture

Contacts and locations

Locations

  • Clinique MEDIPOLE GARONNE

    Toulouse, 31036, France