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Clinical Trials/NCT03441165
NCT03441165
Recruiting
Not Applicable

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

Istituto Ortopedico Rizzoli1 site in 1 country500 target enrollmentFebruary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Musculoskeletal Injury
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
500
Locations
1
Primary Endpoint
Laxity Evaluation
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2018
End Date
June 2032
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefano Zaffagnini

Prof

Istituto Ortopedico Rizzoli

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

Outcomes

Primary Outcomes

Laxity Evaluation

Time Frame: intraoperative

Laxity Evaluation will be performed using the intraoperative navigation system

Secondary Outcomes

  • Dynamic Laxity Evaluation(intraoperative)

Study Sites (1)

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