Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03441165

Acronym

INTRA_KIN

Enrollment

1500

Registered

2018-02-22

Start date

2018-02-10

Completion date

2032-06-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Musculoskeletal Injury

Keywords

ACL, MAT, REVISION, LAXITY

Brief summary

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

PROCEDUREligament reconstruction and meniscus transplantation

ACL reconstruction ACL revision MAT

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Patients who have provided written informed written consent 2. Patients aged 14 to 65 3. 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

1. Patients unable to understand and to want 2. Patients who have not signed informed consent

Design outcomes

Primary

Measure	Time frame	Description
Laxity Evaluation	intraoperative	Laxity Evaluation will be performed using the intraoperative navigation system

Secondary

Measure	Time frame	Description
Dynamic Laxity Evaluation	intraoperative	Laxity Evaluation will be performed using the KiRA device

Countries

Italy

Contacts

CONTACTStefano Zaffagnini

stefano.zaffagnini@unibo.it051 6366075

PRINCIPAL_INVESTIGATORStefano Zaffagnini

stefano.zaffagnini@unibo.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026