ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT (INTRA_KIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03441165
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Stefano Zaffagnini, Istituto Ortopedico Rizzoli

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

Condition or disease Intervention/treatment
Intraoperative Musculoskeletal Injury Procedure: ligament reconstruction and meniscus transplantation

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : July 10, 2018
Estimated Study Completion Date : February 21, 2023

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Laxity Evaluation [ Time Frame: intraoperative ]
    Laxity Evaluation will be performed using the intraoperative navigation system


Secondary Outcome Measures :
  1. Dynamic Laxity Evaluation [ Time Frame: intraoperative ]
    Laxity Evaluation will be performed using the KiRA device



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study aims to include all 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 acquired values (intraoperatively) will be compared both by the surgical navigator and by the KiRA system in order to evaluate the effect of surgery 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 also be made with the lateral limb.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441165


Contacts
Contact: Stefano Zaffagnini 051 6366075 stefano.zaffagnini@unibo.it

Locations
Italy
Stefano Zaffagnini Recruiting
Bologna, Italia, Italy
Contact: Stefano Zaffagnini, MD    051 6366075    stefano.zaffagnini@unibo.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Stefano Zaffagnini stefano.zaffagnini@unibo.it

Responsible Party: Stefano Zaffagnini, Prof, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03441165     History of Changes
Other Study ID Numbers: INTRA_KIN
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefano Zaffagnini, Istituto Ortopedico Rizzoli:
ACL
MAT
REVISION
LAXITY