Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

NCT04183803 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire, Amiens

Phase

Not applicable

Started

2019-11-19

Last updated

2026-05-13

Condition(s) studied

Anterior Cruciate Ligament Injuries

Investigational drug(s) / intervention(s)

anatomic anterior cruciate ligament (ACL) reconstruction

anatomic anterior cruciate ligament (ACL) reconstruction: 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®).

Study 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

Sex

ALL

Min age

10 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Accuracy of tunnel positioning — Day 0; during the operation
Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion

Trial sites (1)

Facility	City	Region	Status
CHU Amiens	Amiens	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04183803 on ClinicalTrials.gov ↗ ← All trials in France