Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: anatomic anterior cruciate ligament (ACL) reconstruction

• Registration Number: NCT04183803
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rosa robot assistance	anatomic anterior cruciate ligament (ACL) reconstruction	Patients with ACL rupture requiring surgical treatment will be included. 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®).

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Knee stability	up to 2 years; during follow-up	Knee stability will be measured with manual test : radiography images.
Range of motion of the knee	day 0, during operation	Range of motion of the knee will be measured with ACL-RSI (Psychological ACL-RSI Score).; Psychological ACL-RSI Score : measure patient psychological impact. This test includes 12 questions. Higher score describes no knee pathology.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France