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

NCT06990100 | Completed

• 1 other identifier: 2024-A01222-45
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Rupture

Outcome Measures

Primary Outcomes (1)

• 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

  2 years post-surgery

Secondary Outcomes (1)

• safety of of the DT4-EBMCA

  2 years post-surgery

Study Arms (1)

ACL rupture group

OTHER

Patients having a surgery with DT4-EBMCA medical device

Device: ACL surgery

Interventions

ACL surgery DEVICE

ligamentoplasty surgery - ACL reconstruction surgery

ACL rupture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• SACIMEX: lead

Study Sites (1)

Clinique MEDIPOLE GARONNE

Toulouse, 31036, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 12, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)