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Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183803
Acronym
MIRRACL
Enrollment
30
Registered
2019-12-03
Start date
2019-11-19
Completion date
2027-09-30
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligament, reconstruction, robot, tunnel

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®).

Interventions

PROCEDUREanatomic 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®).

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of tunnel positioningDay 0; during the operationAccuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion

Secondary

MeasureTime frameDescription
Range of motion of the kneeday 0, during operationRange 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.
Knee stabilityday 0; during operationKnee stability will be measured with manual test : "pivot shift"

Countries

France

Contacts

CONTACTFrançois Deroussen, MD
deroussen.francois@chu-amiens.fr(33)322087576
CONTACTMichel Lefranc, MD
lefranc.michel@chu-amiens.fr(33)22088955
PRINCIPAL_INVESTIGATORFrançois Deroussen, MD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026