Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

Recruiting

• Conditions: Intraoperative Musculoskeletal Injury

• Registration Number: NCT03441165
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2018-02-10
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Primary Completion: 2018-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Completion: 2032-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laxity Evaluation	intraoperative	Laxity Evaluation will be performed using the intraoperative navigation system

Secondary Outcome Measures

Name	Time	Method
Dynamic Laxity Evaluation	intraoperative	Laxity Evaluation will be performed using the KiRA device

Trial Locations

Locations (1)

Stefano Zaffagnini; 🇮🇹 Bologna, Italia, Italy