Anterior Cruciate Ligament (ACL) ReconstructionNCT04462458
M-ARS ACL Post-marketing Surveillance Study
An observational study of Anterior Cruciate Ligament (ACL) Reconstruction, run by Medacta International SA at 3 sites in 2 countries.
Trial summary
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction. The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction
- What is being tested?
- Medacta Anatomic Ribbon Surgery (M-ARS ACL)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2022to Jan 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring ACL reconstruction and who are suitable to receive M-ARS ACL will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Who may be able to join
- Patients older than 18 years
- Patients with ACL rupture requiring ACL reconstruction
Who cannot join
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits of the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Austria2 sites, 2 recruiting
- Recruiting
Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
Innsbruck, 6020
Christian Fink, Prof. Dr. med.
- Recruiting
Pyhrn-Eisenwurzen Klinikum Kirchdorf
Kirchdorf an der Krems, 4560
Simone Danese, OA Dr.
About this study
Official title: Clinical and Radiological Outcomes of M-ARS ACL
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.
The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.
Read the detailed description
This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 1 month ± 15 days post-surgery
- V4: Follow-up visit at 6 months ± 30 days post-surgery
- V5: Follow-up visit at 12 months ± 60 days post-surgery
- V6: Follow-up visit at 24 months ± 90 days post-surgery
The following data will be collected:
- Survival rate of implants evaluating the incidence of implants failure, where implant failure is defined as revision, loosening, or any definite change in the position of components (V3-V6).
- Clinical and functional outcomes, measured with the International Knee Documentation Committee (IKDC) score (V1, V3-V6)
- Quality of Life, measured with the EQ-5D score (V1, V3-V6)
- Occurrence of intraoperative and postoperative complications (V2-V6)
Depending on standard practice, imaging assessment of implants and bone tunnels may be performed.
A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).
The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
- Being tested
- Medacta Anatomic Ribbon Surgery (M-ARS ACL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medacta Anatomic Ribbon Surgery (M-ARS ACL)Device
M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Kaplan Meier method
Measured: 6 months
Secondary outcomes (5)
Survival rate
Kaplan Meier method
Measured: 1, 12, 24 months
Functional outcome
International Knee Documentation Committee (IKDC) score
Measured: 1, 6, 12, 24 months
Quality of Life outcome
EQ-5D score
Measured: 1, 6, 12, 24 months
Radiological outcome (optional)
Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel
Measured: 1, 6, 12, 24 months
Complication rate
Occurrence of intraoperative and postoperative complications
Measured: intraoperative, 1, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jul 2022
- Primary completionJul 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) ReconstructionStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mirco Herbort, Prof. Dr. med., Principal investigator, OCM Klinik GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462458
- Sponsor's protocol ID
- P07.001.01
- Status last verified
- Mar 2023
- First submitted
- 2 Jul 2020
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of M-ARS ACL
- ClinicalTrials.gov ID
- NCT04462458
- Acronym / sponsor ID
- P07.001.01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Jul 2020 (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 goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.
The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.
Detailed description
This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 1 month ± 15 days post-surgery
- V4: Follow-up visit at 6 months ± 30 days post-surgery
- V5: Follow-up visit at 12 months ± 60 days post-surgery
- V6: Follow-up visit at 24 months ± 90 days post-surgery
The following data will be collected:
- Survival rate of implants evaluating the incidence of implants failure, where implant failure is defined as revision, loosening, or any definite change in the position of components (V3-V6).
- Clinical and functional outcomes, measured with the International Knee Documentation Committee (IKDC) score (V1, V3-V6)
- Quality of Life, measured with the EQ-5D score (V1, V3-V6)
- Occurrence of intraoperative and postoperative complications (V2-V6)
Depending on standard practice, imaging assessment of implants and bone tunnels may be performed.
A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).
The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring ACL reconstruction and who are suitable to receive M-ARS ACL will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Key inclusion criteria (2 listed)
- Patients older than 18 years
- Patients with ACL rupture requiring ACL reconstruction
Key exclusion criteria (4 listed)
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits of the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
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 |
|---|---|---|
| Medacta Anatomic Ribbon Surgery (M-ARS ACL)M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique | Device | – |
Primary outcome
Survival rate
Time frame: 6 months
Kaplan Meier method
5 secondary outcomes
Survival rate
Time frame: 1, 12, 24 months
Functional outcome
Time frame: 1, 6, 12, 24 months
Quality of Life outcome
Time frame: 1, 6, 12, 24 months
Radiological outcome (optional)
Time frame: 1, 6, 12, 24 months
Complication rate
Time frame: intraoperative, 1, 6, 12, 24 months
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 13 Mar 2023.
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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.
Mirco Herbort, Prof. Dr. med. principal investigator
OCM Klinik GmbH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament (ACL) Reconstruction, run by Medacta International SA at 3 sites in 2 countries.
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 2 inclusion and 4 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany. 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 Denise Falcone (+41916966060, falcone@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 6 months). 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 13 Mar 2023; AzTrials last refreshed its copy on 26 Oct 2026.