Anterior Cruciate Ligament ReconstructionMULTI-ACLNCT06058494
Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Anterior Cruciate Ligament Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2015to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.
Who may be able to join
- Primary ACL lesion
- Ability to read and sign the informed consent.
- Age between 16 and 50 years old
Who cannot join
- Prior surgeries at the same knee
- Grade II or higher lesions at the collateral ligaments
- Posterior Cruciate Ligament lesion
- Inflammatory arthritis or other forms systemic inflammatory diseases
- Local or systemic infections
- Any injury or condition that adversely affects the ability to walk or to participate to I/II level activities
Show all 9Show fewer
- Previous or concomitant lesions at the contralateral knee
- Skeletal immaturity
- Other potential risk factors for the development of osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.
- Being tested
- Anterior Cruciate Ligament Reconstruction
- Keywords
- Anterior Cruciate Ligament, Reconstruction, Ligament modeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cruciate Ligament ReconstructionProcedure or surgery
Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.
| Study group | Role | What they receive |
|---|---|---|
| Single-Bundle | Single-bundle ACL reconstruction Receives: Procedure: Anterior Cruciate Ligament Reconstruction | |
| Single-Bundle+Lateral Plasty | Single-bundle ACL reconstruction with lateral plasty Receives: Procedure: Anterior Cruciate Ligament Reconstruction | |
| Double-Bundle | Double-bundle ACL reconstruction Receives: Procedure: Anterior Cruciate Ligament Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Measured: At baseline
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Measured: 4 months
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Measured: 18 months
Secondary outcomes (2)
Functional and Anatomical Model
MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.
Measured: at 4 months
Functional and Anatomical Model
MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Nov 2015
- Primary completion1 Nov 2017
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Stefano Zaffagnini, Prof, MD, Principal investigator, Istituto Ortopedico RizzoliNicola Francesco Lopomo, Prof, Study director, Istituto Ortopedico RizzoliCecilia Signorelli, PhD, Study chair, Istituto Ortopedico RizzoliMarco Bontempi, PhD, Study chair, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058494
- Sponsor's protocol ID
- 0023352
- Acronym
- MULTI-ACL
- Status last verified
- Sep 2023
- First submitted
- 25 May 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06058494
- Acronym / sponsor ID
- MULTI-ACL / 0023352
- Keywords
- Anterior Cruciate Ligament, Reconstruction, Ligament modeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Sep 2023 (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.
The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-Bundle | – | Procedure: Anterior Cruciate Ligament ReconstructionSingle-bundle ACL reconstruction |
| Single-Bundle+Lateral Plasty | – | Procedure: Anterior Cruciate Ligament ReconstructionSingle-bundle ACL reconstruction with lateral plasty |
| Double-Bundle | – | Procedure: Anterior Cruciate Ligament ReconstructionDouble-bundle ACL reconstruction |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.
Key inclusion criteria (3 listed)
- Primary ACL lesion
- Ability to read and sign the informed consent.
- Age between 16 and 50 years old
Key exclusion criteria (9 listed)
- Prior surgeries at the same knee
- Grade II or higher lesions at the collateral ligaments
- Posterior Cruciate Ligament lesion
- Inflammatory arthritis or other forms systemic inflammatory diseases
- Local or systemic infections
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 |
|---|---|---|
| Anterior Cruciate Ligament ReconstructionReconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle. | Procedure or surgery | Double-Bundle, Single-Bundle, Single-Bundle+Lateral Plasty |
Primary outcome
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Time frame: At baseline
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Time frame: 4 months
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics
Time frame: 18 months
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
2 secondary outcomes
Functional and Anatomical Model
Time frame: at 4 months
Functional and Anatomical Model
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Institutional WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Stefano Zaffagnini, Prof, MD principal investigator
Istituto Ortopedico Rizzoli
Nicola Francesco Lopomo, Prof study director
Istituto Ortopedico Rizzoli
Cecilia Signorelli, PhD study chair
Istituto Ortopedico Rizzoli
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 Anterior Cruciate Ligament Reconstruction, 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 9 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics (time frame: At baseline). The study lists 3 primary outcomes in all. 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 28 Sep 2023.