Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

NCT ID: NCT03441165

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-10

Study Completion Date

2032-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraoperative Musculoskeletal Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ligament reconstruction and meniscus transplantation

ACL reconstruction ACL revision MAT

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Stefano Zaffagnini

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefano Zaffagnini

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Stefano Zaffagnini

Bologna, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Zaffagnini

Role: CONTACT

051 6366075

Facility Contacts

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Stefano Zaffagnini, MD

Role: primary

051 6366075

Other Identifiers

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INTRA_KIN

Identifier Type: -

Identifier Source: org_study_id

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