Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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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®).

Official Title
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Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: anatomic anterior cruciate ligament (ACL) reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rosa robot assistance<br>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®). | Procedure: anatomic anterior cruciate ligament (ACL) reconstruction<br>* 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®).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of tunnel positioning | Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion | Day 0; during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion of the knee | Range of motion of the knee will be measured with IKCD score (International Knee Documentation Committee) IKCD score : The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function. | day 0, during operation | 
| Range of motion of the knee | Range of motion of the knee will be measured with IKCD score (International Knee Documentation Committee) IKCD score : The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function. | up to 2 years; during follow-up | 
| Range of motion of the knee | Range of motion of the knee will be measured with Lysholm (Lysholm Knee Score) Lysholm Knee Score : measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning. | up to 2 years; during follow-up | 
| Range of motion of the knee | Range of motion of the knee will be measured with Lysholm (Lysholm Knee Score) Lysholm Knee Score : measure the domain of functioning in sports and recreational activities. This scale consists of eight items. It is scored on a scale of 0 to 100, with higher scores indicating fewer symptoms and higher levels of functioning. | day 0, during operation | 
| Range of motion of the knee | 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. | up to 2 years; during follow-up | 
| Range of motion of the knee | 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. | day 0, during operation | 
| Knee stability | Knee stability will be measured with manual test : pivot shift | day 0; during operation | 
| Knee stability | Knee stability will be measured with manual test : radiography images. | day 0; during operation | 
| Knee stability | Knee stability will be measured with manual test : pivot shift | up to 2 years; during follow-up | 
| Knee stability | Knee stability will be measured with manual test : radiography images. | up to 2 years; during follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament, reconstruction, robot, tunnel