Status:
COMPLETED
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
Lead Sponsor:
SACIMEX
Conditions:
ACL Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
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 effecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06990100
Start Date
October 1 2024
End Date
May 12 2025
Last Update
May 25 2025
Active Locations (1)
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1
Clinique MEDIPOLE GARONNE
Toulouse, France, 31036