Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
NCT ID: NCT06990100
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2024-10-01
2025-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACL rupture group
Patients having a surgery with DT4-EBMCA medical device
ACL surgery
ligamentoplasty surgery - ACL reconstruction surgery
Interventions
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ACL surgery
ligamentoplasty surgery - ACL reconstruction surgery
Eligibility Criteria
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Inclusion Criteria
* Patient having answer to IKDC and KOOS pre-operative
* Patient having received information and signed informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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SACIMEX
INDUSTRY
Responsible Party
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Locations
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Clinique MEDIPOLE GARONNE
Toulouse, , France
Countries
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Other Identifiers
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2024-A01222-45
Identifier Type: -
Identifier Source: org_study_id
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