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OpenTrials
Completed

NCT Number: NCT06990100

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique MEDIPOLE GARONNE

Toulouse, 31036, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACL surgery

Device

ligamentoplasty surgery - ACL reconstruction surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. safety of of the DT4-EBMCA

    Time frame: 2 years post-surgery

    Mean rate of complications from the preoperative visit to the postoperative 2 years follow-up Re-rupture ≤ 2,5%

Sponsors and collaborators

Lead sponsor

SACIMEX

Industry

Registry information

Official study title

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

Acronym: DT4-EBMCA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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