Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction (MIRRACL)
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anatomic anterior cruciate ligament (ACL) reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring anterior cruciate ligament, reconstruction, robot, tunnel
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rosa robot assistance
Arm Description
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®).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Knee stability
Knee stability will be measured with manual test : "pivot shift"
Knee stability
Knee stability will be measured with manual test : radiography images.
Knee stability
Knee stability will be measured with manual test : "pivot shift"
Knee stability
Knee stability will be measured with manual test : radiography images.
Full Information
NCT ID
NCT04183803
First Posted
November 21, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04183803
Brief Title
Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
Acronym
MIRRACL
Official Title
Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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®).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
anterior cruciate ligament, reconstruction, robot, tunnel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rosa robot assistance
Arm Type
Experimental
Arm Description
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®).
Intervention Type
Procedure
Intervention Name(s)
anatomic anterior cruciate ligament (ACL) reconstruction
Intervention Description
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 Measure Information:
Title
Accuracy of tunnel positioning
Description
Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion
Time Frame
Day 0; during the operation
Secondary Outcome Measure Information:
Title
Range of motion of the knee
Description
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.
Time Frame
day 0, during operation
Title
Range of motion of the knee
Description
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.
Time Frame
up to 2 years; during follow-up
Title
Range of motion of the knee
Description
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.
Time Frame
up to 2 years; during follow-up
Title
Range of motion of the knee
Description
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.
Time Frame
day 0, during operation
Title
Range of motion of the knee
Description
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.
Time Frame
up to 2 years; during follow-up
Title
Range of motion of the knee
Description
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.
Time Frame
day 0, during operation
Title
Knee stability
Description
Knee stability will be measured with manual test : "pivot shift"
Time Frame
day 0; during operation
Title
Knee stability
Description
Knee stability will be measured with manual test : radiography images.
Time Frame
day 0; during operation
Title
Knee stability
Description
Knee stability will be measured with manual test : "pivot shift"
Time Frame
up to 2 years; during follow-up
Title
Knee stability
Description
Knee stability will be measured with manual test : radiography images.
Time Frame
up to 2 years; during follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Deroussen, MD
Phone
(33)322087576
Email
deroussen.francois@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Lefranc, MD
Phone
(33)22088955
Email
lefranc.michel@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Deroussen, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Deroussen, MD
Phone
(33)322087576
Email
deroussen.francois@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Michel Lefranc, MD
Phone
(33)322088955
Email
lefranc.michel@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Antoine Gabrion, Pr
First Name & Middle Initial & Last Name & Degree
Richard Gouron, Pr
First Name & Middle Initial & Last Name & Degree
Céline Klein, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
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