Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction (MIRRACL)

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®).

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Procedure: anatomic anterior cruciate ligament (ACL) reconstruction

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rosa robot assistance; 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; 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®).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: robot; reconstruction; anterior cruciate ligament; tunnel
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: PI2019_843_0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No