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

Not Applicable

Completed

• Conditions: ACL Rupture

• Registration Number: NCT06990100
• Lead Sponsor: SACIMEX

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Primary Completion: 2025-04-01
• Status Verified: 2025-05
• Study Completion: 2025-05-12
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Clinique MEDIPOLE GARONNE; 🇫🇷 Toulouse, France