Anterior Cruciate Ligament InjuriesNCT05791656
Interference Screw Mectascrew-C Postmarket Study
An observational study of Anterior Cruciate Ligament Injuries and Posterior Cruciate Ligament Tear, run by Medacta International SA at 1 site in Switzerland.
Trial summary
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Posterior Cruciate Ligament Tear
- What is being tested?
- Mectascrew-C
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Mar 2023to Mar 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/exclusion criteria
Who may be able to join
- Patients of both sexes aged 16-60 yrs
- Pre-operative MRI confirming the ACL or PCL rupture
- Scheduled for surgical reconstruction of ACL or PCL
- BMI>18 and <35 kg/m2
- Ability to give informed consent by signature
Who cannot join
- Age under 16 or over 60 yrs
- Degenerative osteopathies
- Local bone tumors
- Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
- Systemic diseases and metabolic disorders that may compromise the outcome of the surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
EOC, Service of Orthopaedics and Traumatology
Lugano, CH-6962
Alessandro Sangiorgio, Dr, Alessandro.Sangiorgio@eoc.ch
Christian Candrian, Prof Dr Med
About this study
Official title: Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
Read the detailed description
This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).
The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.
The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms
- Being tested
- Mectascrew-C
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mectascrew-CDevice
reconstruction of ACL or PCL rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference screw presence
via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed
Measured: 6 months
Secondary outcomes (7)
Mobility outcomes evaluation
Assessment throught Range Of Motion of operated knee calculated as degree
Measured: 1, 3 and 6 months
Functional outcomes evaluation
Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 1, 3 and 6 months
Knee stability evaluation of ACL intervention
Pivot shift test. A positive test indicate an injury at ACL
Measured: 1, 3 and 6 months
ACL integrity assessment
Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Measured: 1, 3 and 6 months
Knee stability evaluation of PCL intervention
Reverse Pivot Shift test. In the presence of a posterolateral injury with the knee flexed, the tibia follows gravity and drops into posterolateral subluxation (positive Reverse Pivot Shift Test).
Measured: 1, 3 and 6 months
PCL integrity assessment
Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation.
Measured: 1, 3 and 6 months
Device safety evaluation
collection of adverse event
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start22 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (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 InjuriesStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Candrian, Prof Med, Principal investigator, EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791656
- Sponsor's protocol ID
- P07.001.09
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2023
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05791656
- Acronym / sponsor ID
- P07.001.09
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Mar 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.
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
Detailed description
This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).
The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.
The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/exclusion criteria
Key inclusion criteria (5 listed)
- Patients of both sexes aged 16-60 yrs
- Pre-operative MRI confirming the ACL or PCL rupture
- Scheduled for surgical reconstruction of ACL or PCL
- BMI>18 and <35 kg/m2
- Ability to give informed consent by signature
Key exclusion criteria (5 listed)
- Age under 16 or over 60 yrs
- Degenerative osteopathies
- Local bone tumors
- Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
- Systemic diseases and metabolic disorders that may compromise the outcome of the 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 |
|---|---|---|
| Mectascrew-Creconstruction of ACL or PCL rupture | Device | – |
Primary outcome
Interference screw presence
Time frame: 6 months
via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed
7 secondary outcomes
Mobility outcomes evaluation
Time frame: 1, 3 and 6 months
Functional outcomes evaluation
Time frame: 1, 3 and 6 months
Knee stability evaluation of ACL intervention
Time frame: 1, 3 and 6 months
ACL integrity assessment
Time frame: 1, 3 and 6 months
Knee stability evaluation of PCL intervention
Time frame: 1, 3 and 6 months
PCL integrity assessment
Time frame: 1, 3 and 6 months
Device safety evaluation
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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.
Christian Candrian, Prof Med principal investigator
EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)
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 Injuries and Posterior Cruciate Ligament Tear, run by Medacta International SA at 1 site in Switzerland.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Bonacina, PhD (+41 91 696 60 60, bonacina@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference screw presence (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 1 May 2024.