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

SACIMEX

Status

Completed

Conditions

ACL Rupture

Treatments

Device: ACL surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT06990100

2024-A01222-45

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.