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

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ClinicalTrials.gov Identifier: NCT04183803
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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®).


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: anatomic anterior cruciate ligament (ACL) reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rosa robot assistance
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®).
Procedure: anatomic 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®).




Primary Outcome Measures :
  1. Accuracy of tunnel positioning [ 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


Secondary Outcome Measures :
  1. Range of motion of the knee [ 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.

  2. Range of motion of the knee [ 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.

  3. Range of motion of the knee [ 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.


  4. Range of motion of the knee [ 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.


  5. Range of motion of the knee [ 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.


  6. Range of motion of the knee [ 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.


  7. Knee stability [ Time Frame: day 0; during operation ]
    Knee stability will be measured with manual test : "pivot shift"

  8. Knee stability [ Time Frame: day 0; during operation ]
    Knee stability will be measured with manual test : radiography images.

  9. Knee stability [ Time Frame: up to 2 years; during follow-up ]
    Knee stability will be measured with manual test : "pivot shift"

  10. Knee stability [ Time Frame: up to 2 years; during follow-up ]
    Knee stability will be measured with manual test : radiography images.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183803


Contacts
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Contact: François Deroussen, MD (33)322087576 deroussen.francois@chu-amiens.fr
Contact: Michel Lefranc, MD (33)22088955 lefranc.michel@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Francois Deroussen, MD    (33)322087576    deroussen.francois@chu-amiens.fr   
Contact: Michel Lefranc, MD    (33)322088955    lefranc.michel@chu-amiens.fr   
Principal Investigator: Antoine Gabrion, Pr         
Principal Investigator: Richard Gouron, Pr         
Principal Investigator: Céline Klein, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: François Deroussen, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04183803    
Other Study ID Numbers: PI2019_843_0029
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
anterior cruciate ligament
reconstruction
robot
tunnel
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries