Intraoperative Musculoskeletal InjuryINTRA_KINNCT03441165
Intraoperative Laxity Assessment of ACL Reconstruction, ACL Revision and MAT
An observational study of Intraoperative Musculoskeletal Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL revision, MAT Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Intraoperative Musculoskeletal Injury
- What is being tested?
- ligament reconstruction and meniscus transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2018to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who have provided written informed written consent
- Patients aged 14 to 65
- 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
Who cannot join
- Patients unable to understand and to want
- Patients who have not signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Stefano Zaffagnini
Bologna, Italia
Stefano Zaffagnini, MD, 051 6366075, stefano.zaffagnini@unibo.it
About this study
Official title: Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL revision, MAT
Read the 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.
- Conditions
- Intraoperative Musculoskeletal Injury
- Being tested
- ligament reconstruction and meniscus transplantation
- Keywords
- ACL, MAT, REVISION, LAXITY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligament reconstruction and meniscus transplantationProcedure or surgery
ACL reconstruction ACL revision MAT
What is being measured
The primary outcome is the main question the study is designed to answer.
Laxity Evaluation
Laxity Evaluation will be performed using the intraoperative navigation system
Measured: intraoperative
Secondary outcomes (1)
Dynamic Laxity Evaluation
Laxity Evaluation will be performed using the KiRA device
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start10 Feb 2018
- Primary completion10 Jul 2018
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
- Investigators
- Stefano Zaffagnini, Principal investigator, stefano.zaffagnini@unibo.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441165
- Sponsor's protocol ID
- INTRA_KIN
- Acronym
- INTRA_KIN
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
- ClinicalTrials.gov ID
- NCT03441165
- Acronym / sponsor ID
- INTRA_KIN / INTRA_KIN
- Conditions
- Intraoperative Musculoskeletal Injury
- Keywords
- ACL, MAT, REVISION, LAXITY
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- Jun 2032 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients who have provided written informed written consent
- Patients aged 14 to 65
- 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
Key exclusion criteria (2 listed)
- Patients unable to understand and to want
- Patients who have not signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ligament reconstruction and meniscus transplantationACL reconstruction ACL revision MAT | Procedure or surgery | – |
Primary outcome
Laxity Evaluation
Time frame: intraoperative
Laxity Evaluation will be performed using the intraoperative navigation system
1 secondary outcome
Dynamic Laxity Evaluation
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Zaffagnini principal investigator
stefano.zaffagnini@unibo.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Musculoskeletal Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Zaffagnini (051 6366075, stefano.zaffagnini@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laxity Evaluation (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.