Clinical trial NCT03441165: Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT
Official title: Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraoperative Musculoskeletal Injury
Keywords: ACL
MAT
REVISION
LAXITY
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Laxity Evaluation
timeFrame: intraoperative
Secondary outcomes:
measure: Dynamic Laxity Evaluation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Stefano Zaffagnini
state: Italia
Study officials:
affiliation: stefano.zaffagnini@unibo.it
name: Stefano Zaffagnini
role: PRINCIPAL_INVESTIGATOR
References: