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Recruiting NCT04183803

Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

No phase Interventional Anterior Cruciate Ligament Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anatomic anterior cruciate ligament (ACL) reconstruction.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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®).

Interventions

  • 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

  • Accuracy of tunnel positioning [Time frame: Day 0; during the operation]
Secondary outcome measures (10)
  • Range of motion of the knee [Time frame: day 0, during operation]
  • Range of motion of the knee [Time frame: up to 2 years; during follow-up]
  • Range of motion of the knee [Time frame: up to 2 years; during follow-up]
  • Range of motion of the knee [Time frame: day 0, during operation]
  • Range of motion of the knee [Time frame: up to 2 years; during follow-up]
  • Range of motion of the knee [Time frame: day 0, during operation]
  • Knee stability [Time frame: day 0; during operation]
  • Knee stability [Time frame: day 0; during operation]
  • Knee stability [Time frame: up to 2 years; during follow-up]
  • Knee stability [Time frame: up to 2 years; during follow-up]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT04183803 · PI2019_843_0029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗