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Recruiting NCT03441165

Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

— Observational Intraoperative Musculoskeletal Injury

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: ligament reconstruction and meniscus transplantation.
Who it may be relevant to
Registry conditions: Intraoperative Musculoskeletal Injury. Basic parameters: 14 years — 65 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
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation

Overview

Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL revision, MAT

Detailed description

The study aims to include all thise patients who will undergo anterior cruciate ligament reconstruction, anterior cruciate ligament revision or meniscus transplantation. These patients will undergo an intraoperative kinematic evaluation (pre- and post-ligament reconstruction / meniscal transplantation). There is no follow-up because all the data necessary to carry out the study are obtained during the operating session. In particular, the pre- and post-intervention values (acquired intraoperatively) will be compared using both the surgical navigator and the KiRA system in order to evaluate the effect of the surgical procedure on the value of both static and dynamic laxity of the knee joint. Moreover, limited to the data acquired with the KiRA system, a comparison will be also made with the controlateral limb.

Interventions

  • Procedure ligament reconstruction and meniscus transplantation
    ACL reconstruction ACL revision MAT

Primary outcome measures

  • Laxity Evaluation [Time frame: intraoperative]
Secondary outcome measures (1)
  • Dynamic Laxity Evaluation [Time frame: intraoperative]

Eligibility criteria

Inclusion criteria

  • Patients who have provided written informed written consent
  • Patients aged 14 to 65
  • Patients undergoing reconstructive surgery of the anterior cruciate ligament or revision of anterior cruciate ligament surgery or meniscus transplantation. Patients unable to understand and want patients who have not signed informed consent

Exclusion criteria

  • Patients unable to understand and to want
  • Patients who have not signed 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

Observational model
Cohort

Study locations

Italy · 1 center
  • Stefano Zaffagnini — Bologna

Identifiers

NCT: NCT03441165 · INTRA_KIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗