ACL RuptureDT4-EBMCANCT06990100
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery
A study testing ACL surgery in people with ACL Rupture, run by SACIMEX at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Rupture
- What is being tested?
- ACL surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 12 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. This study evaluates its long-term performance and safety in routine clinical practice.
- Conditions
- ACL Rupture
- Being tested
- ACL surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL surgeryDevice
ligamentoplasty surgery - ACL reconstruction surgery
| Study group | Role | What they receive |
|---|---|---|
| ACL rupture group | Other | Patients having a surgery with DT4-EBMCA medical device Receives: Device: ACL surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the performance of the DT4- EBMCA
International Knee Documentation Committee (IKDC) from the preoperative visit to the postoperative 2 years follow-up Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative visit to the postoperative 2 years follow-up
Measured: 2 years post-surgery
Secondary outcomes (1)
safety of of the DT4-EBMCA
Mean rate of complications from the preoperative visit to the postoperative 2 years follow-up Re-rupture ≤ 2,5%
Measured: 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Oct 2024
- Primary completion1 Apr 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL RuptureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SACIMEX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990100
- Sponsor's protocol ID
- 2024-A01222-45
- Acronym
- DT4-EBMCA
- Status last verified
- Apr 2026
- First submitted
- 18 May 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06990100
- Acronym / sponsor ID
- DT4-EBMCA / 2024-A01222-45
- Conditions
- ACL Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SACIMEXIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 25 May 2025 (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.
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. This study evaluates its long-term performance and safety in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL rupture group | Other | Device: ACL surgeryPatients having a surgery with DT4-EBMCA medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| ACL surgeryligamentoplasty surgery - ACL reconstruction surgery | Device | ACL rupture group |
Primary outcome
evaluate the performance of the DT4- EBMCA
Time frame: 2 years post-surgery
International Knee Documentation Committee (IKDC) from the preoperative visit to the postoperative 2 years follow-up Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative visit to the postoperative 2 years follow-up
1 secondary outcome
safety of of the DT4-EBMCA
Time frame: 2 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL surgery in people with ACL Rupture, run by SACIMEX 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 27 Apr 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the performance of the DT4- EBMCA (time frame: 2 years post-surgery). 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 27 Apr 2026.