Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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®).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • anatomic anterior cruciate ligament (ACL) reconstruction

    Procedure/Surgery

    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 groups

30 Participants
are divided into 1 treatment group
Group A: rosa robot assistanceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0; during the operation

Secondary outcomes

1

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.

Time frame
day 0, during operation
2

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.

Time frame
up to 2 years; during follow-up
3

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.

Time frame
up to 2 years; during follow-up
4

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.

Time frame
day 0, during operation

Other outcomes

Sponsors and contacts

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