Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

NCT04183803 | Recruiting

• 1 other identifier: PI2019_843_0029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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®).

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligament; reconstruction; robot; tunnel

Outcome Measures

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

  Day 0; during the operation

Secondary Outcomes (10)

• Range of motion of the knee

  day 0, during operation

• Range of motion of the knee

  up to 2 years; during follow-up

• Range of motion of the knee

  up to 2 years; during follow-up

• Range of motion of the knee

  day 0, during operation

• Range of motion of the knee

  up to 2 years; during follow-up

Study Arms (1)

rosa robot assistance

EXPERIMENTAL

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

Interventions

anatomic anterior cruciate ligament (ACL) reconstruction 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®).

rosa robot assistance

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• François Deroussen, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Deroussen, MD

CONTACT

(33)322087576; deroussen.francois@chu-amiens.fr

Michel Lefranc, MD

CONTACT

(33)22088955; lefranc.michel@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 3, 2019
• Study Start: November 19, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)