Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04183803

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2025-11-30

Brief Summary

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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®).

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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®).

Group Type EXPERIMENTAL

anatomic anterior cruciate ligament (ACL) reconstruction

Intervention Type PROCEDURE

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

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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®).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Deroussen, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François Deroussen, MD

Role: CONTACT

(33)322087576

Michel Lefranc, MD

Role: CONTACT

(33)22088955

Facility Contacts

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Francois Deroussen, MD

Role: primary

(33)322087576

Michel Lefranc, MD

Role: backup

(33)322088955

Other Identifiers

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PI2019_843_0029

Identifier Type: -

Identifier Source: org_study_id

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