Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament TearNCT06166784
Interference Screw Mectascrew-B Postmarket Study
An observational study of Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear, run by Medacta International SA at 1 site in Germany.
Trial summary
An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) 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 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear
- What is being tested?
- Mectascrew B
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2023to Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/ exclusion criteria
Who may be able to join
- Both genders
- Patients older than 18 years
- ACL or PCL damage requiring primary ACL or PCL reconstruction
- Patient requiring ACL or PCL surgery with the use of Medacta MectaScrew B interference screw, according to Manufacturer IFU's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts
- Patients who are willing to participate in the study and have signed informed consent form.
Who cannot join
- Patients with contraindications according to IFU's
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits on the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
- Concomitant ligament injury (grade ≥ 3)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
OCM Klinik GmbH
Münich, 81369
Mirco Herbort, Prof Dr, +49 89.206082-0, Mirco.Herbort@ocm-muenchen.de
Mirco Herbort, Prof Dr Med
About this study
Official title: Cinical Outcomes of Mectascrew B Interference Screw
An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) 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 toassess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) at 12 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at OCM Klnik GmbH hospital 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-B, Medacta International SA). Data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, 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 by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. 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 B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mectascrew BDevice
reconstruction of ACL or PCL rupture
| Study group | Role | What they receive |
|---|---|---|
| Mectascrew B | Not described Receives: Device: Mectascrew B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 12 months
Secondary outcomes (7)
Mobility outcomes evaluation
Assessment throught Range Of Motion of operated knee calculated as degree
Measured: 6 weeks, 6 months, 12 months
Knee stability evaluation of ACL intervention
Pivot shift test. A positive test indicate an injury at ACL
Measured: 6 weeks, 6 months, 12 months
ACL integrity assessment
Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL
Measured: 6 weeks, 6 months, 12 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: 6 weeks, 6 months, 12 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: 6 weeks, 6 months, 12 months
Interference screw integration
Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel by std x-ray
Measured: 6 weeks, 6 months, 12 months
Incidence of adverse event
collection of adverse event
Measured: 6 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start19 Oct 2023
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (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 Injuries Posterior Cruciate Ligament TearStudies 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166784
- Sponsor's protocol ID
- P07.001.08
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 12 Dec 2023
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cinical Outcomes of Mectascrew B Interference Screw
- ClinicalTrials.gov ID
- NCT06166784
- Acronym / sponsor ID
- P07.001.08
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Dec 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 assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) 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 toassess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) at 12 months following ACL or PCL reconstruction.
Patients with an ACL or PCL tear scheduled for surgery at OCM Klnik GmbH hospital 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-B, Medacta International SA). Data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, 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 by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mectascrew B | – | Device: Mectascrew B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/ exclusion criteria
Key inclusion criteria (5 listed)
- Both genders
- Patients older than 18 years
- ACL or PCL damage requiring primary ACL or PCL reconstruction
- Patient requiring ACL or PCL surgery with the use of Medacta MectaScrew B interference screw, according to Manufacturer IFU's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts
- Patients who are willing to participate in the study and have signed informed consent form.
Key exclusion criteria (6 listed)
- Patients with contraindications according to IFU's
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits on 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 |
|---|---|---|
| Mectascrew Breconstruction of ACL or PCL rupture | Device | Mectascrew B |
Primary outcome
Functional outcomes evaluation
Time frame: 12 months
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).
7 secondary outcomes
Mobility outcomes evaluation
Time frame: 6 weeks, 6 months, 12 months
Knee stability evaluation of ACL intervention
Time frame: 6 weeks, 6 months, 12 months
ACL integrity assessment
Time frame: 6 weeks, 6 months, 12 months
Knee stability evaluation of PCL intervention
Time frame: 6 weeks, 6 months, 12 months
PCL integrity assessment
Time frame: 6 weeks, 6 months, 12 months
Interference screw integration
Time frame: 6 weeks, 6 months, 12 months
Incidence of adverse event
Time frame: 6 weeks, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
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 Posterior Cruciate Ligament Tear, run by Medacta International SA at 1 site in Germany.
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 6 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 12 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes evaluation (time frame: 12 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 12 Dec 2023.