NCT04183803 Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
| NCT ID | NCT04183803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-11-19 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2019-11-19 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge. A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess. The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
Eligibility Criteria
Inclusion Criteria: * All patients treated at CHU Amiens-Picardie for ACL reconstruction by practitioner who has robot experience. * children and adults from 10 to 45 years old Exclusion Criteria: * Patients managed by another ACL reconstruction technique * Patients under guardianship, curators deprived of liberty * Pregnant and nursing women. * Patient who refused to participate in the study and to sign informed consent
Contact & Investigator
François Deroussen, MD
PRINCIPAL INVESTIGATOR
CHU Amiens
Frequently Asked Questions
Who can join the NCT04183803 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04183803 currently recruiting?
Yes, NCT04183803 is actively recruiting participants. Contact the research team at deroussen.francois@chu-amiens.fr for enrollment information.
Where is the NCT04183803 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT04183803 clinical trial?
NCT04183803 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is François Deroussen, MD at CHU Amiens. The trial plans to enroll 30 participants.