Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery

Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06990100

Acronym

DT4-EBMCA

Enrollment

Registered

2025-05-25

Start date

2024-10-01

Completion date

2025-05-12

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Rupture

Brief 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. This study evaluates its long-term performance and safety in routine clinical practice.

Interventions

DEVICEACL surgery

ligamentoplasty surgery - ACL reconstruction surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
evaluate the performance of the DT4- EBMCA	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

Secondary

Measure	Time frame	Description
safety of of the DT4-EBMCA	2 years post-surgery	Mean rate of complications from the preoperative visit to the postoperative 2 years follow-up Re-rupture ≤ 2,5%

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026