NCT Number: NCT04183803
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®).
Interested in participating?
Request Info10 year and older
All sexes
Interventional
Not applicable
Amiens, 80054, France
Location status: Recruiting
Antoine Gabrion, Pr
PRINCIPAL_INVESTIGATOR
Céline Klein, MD
PRINCIPAL_INVESTIGATOR
Francois Deroussen, MD
CONTACT
Michel Lefranc, MD
CONTACT
Richard Gouron, Pr
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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®).
Time frame: 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
Time frame: day 0, during operation
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
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
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
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
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
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
Knee stability will be measured with manual test : "pivot shift"
Time frame: day 0; during operation
Knee stability will be measured with manual test : radiography images.
Time frame: up to 2 years; during follow-up
Knee stability will be measured with manual test : "pivot shift"
Time frame: up to 2 years; during follow-up
Knee stability will be measured with manual test : radiography images.
Contact information is provided by the study sponsor or research team.
François Deroussen, MD
CONTACT
Michel Lefranc, MD
CONTACT
Centre Hospitalier Universitaire, Amiens
Other
Acronym: MIRRACL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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