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Recruiting

NCT Number: NCT03441165

Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

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

Recruiting

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stefano Zaffagnini

Bologna, Italia, Italy

Location status: Recruiting

Location contact

Stefano Zaffagnini, MD

CONTACT

[email protected]

051 6366075

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ligament reconstruction and meniscus transplantation

Procedure

ACL reconstruction ACL revision MAT

Primary outcomes

  1. Laxity Evaluation

    Time frame: intraoperative

    Laxity Evaluation will be performed using the intraoperative navigation system

Secondary outcomes

  1. Dynamic Laxity Evaluation

    Time frame: intraoperative

    Laxity Evaluation will be performed using the KiRA device

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Zaffagnini

CONTACT

[email protected]

051 6366075

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: INTRA_KIN

Important dates

Study start
2018
Primary completion
2018
Study completion
2032
First posted
Feb 22, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.