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

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Anterior Cruciate Ligament Injuries

Treatments

Procedure: anatomic anterior cruciate ligament (ACL) reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT04183803
PI2019_843_0029

Details and patient eligibility

About

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®).

Enrollment

30 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

rosa robot assistance
Experimental group
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®).
Treatment:
Procedure: anatomic anterior cruciate ligament (ACL) reconstruction

Trial contacts and locations

1

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Central trial contact

Michel Lefranc, MD; François Deroussen, MD

Data sourced from clinicaltrials.gov

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