Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT

Intraoperative Musculoskeletal Injury Clinical Trial

— INTRA_KIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03441165
• Other study ID #: INTRA_KIN
• Status: Active, not recruiting
• Start date: February 10, 2018
• Est. completion date: June 21, 2024

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 21, 2024
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Musculoskeletal Injury

Intervention

Procedure:
• ligament reconstruction and meniscus transplantation
ACL reconstruction ACL revision MAT

Locations

Country	Name	City	State
Italy	Stefano Zaffagnini	Bologna	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laxity Evaluation	Laxity Evaluation will be performed using the intraoperative navigation system	intraoperative
Secondary	Dynamic Laxity Evaluation	Laxity Evaluation will be performed using the KiRA device	intraoperative