Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

— MIRRACL  

Official title:

Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183803
• Other study ID #: PI2019_843_0029
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: November 2025

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: François Deroussen, MD
• Phone: (33)322087576
• Email: deroussen.francois[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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®).

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Knee stability	Knee stability will be measured with manual test : "pivot shift"	day 0; during operation
Secondary	Knee stability	Knee stability will be measured with manual test : radiography images.	day 0; during operation
Secondary	Knee stability	Knee stability will be measured with manual test : "pivot shift"	up to 2 years; during follow-up
Secondary	Knee stability	Knee stability will be measured with manual test : radiography images.	up to 2 years; during follow-up