Knee Ligament InjuryNCT07864337
Post Market Clinical Follow-up of LARS® Ligaments Associated to Fixations in Acute or Chronic Injury of the Anterior Cruciate Ligament (ACL), Posterior Cruciate (PCL) or Medial Collateral (MCL) Ligaments of the Knee
An observational study of Knee Ligament Injury, run by MOVMEDIX.
Trial summary
This study aims to assess the long-term safety, stability, knee function, pain, and satisfaction of patients who received a LARS® ligament to treat an injury of one of the main ligaments of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Ligament Injury
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- 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: Male or female patient who underwent ligamentoplasty in 1 Knee (1leg) using one or more LARS® artificial ligaments, with or without associated fixation devices between 2015 and 2018.
Who may be able to join
- Patient who received study information and provided informed consent to participate in the study, where required by applicable local regulations and ethics committee requirements.
- Patient who underwent ligamentoplasty using one or more LARS® artificial ligaments for posterior cruciate ligament (PCL), anterior cruciate ligament (ACL), and/or medial collateral ligament (MCL) in only 1 leg (knee) reconstruction between 2015 and 2018 (or since 9 to 12 years from data collection time-point).
- Surgical procedure performed using LARS® ligaments in accordance with the intended use and routine clinical practice.
- Availability of adequate medical records and follow-up documentation allowing assessment of the study endpoints related to safety and performance
Who cannot join
- Patients aged less than 18 years at the time of the ligamentoplasty procedure.
- Patients presenting, at the date of surgery, with any contraindication to ligamentoplasty procedures and/or contraindications specified in the applicable Instructions for Use (IFU) of the implanted device.
- Patients who are lost to follow-up, deceased at the time of study conduct.
- Patients who have undergone bilateral ligamentoplasty.
- Patients belonging to a protected or vulnerable population, including individuals under guardianship, curatorship, legal protection measures, or any other condition limiting their ability to provide informed consent in accordance with applicable local regulations.
- Patients for whom the implanted ligament and/or associated fixation devices cannot be reliably identified from the available documentation.
About this study
This study aims to assess the long-term safety, stability, knee function, pain, and satisfaction of patients who received a LARS® ligament to treat an injury of one of the main ligaments of the knee.
Read the detailed description
This is a multicenter observational PMCF study combining retrospective collection of historical clinical data with a prospective 10-year follow-up assessment, including a evaluation of device status, patient-reported outcomes and knee stability.
- Conditions
- Knee Ligament Injury
- Keywords
- LARS® ligament, Artificial knee ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCL32 | Patients who received MCL32 ligament, 51 patients | |
| ACL AC30DB/AC60DB | Patients who received ACL AC30DB/AC60DB ligament, 64 patients | |
| ACL ACTOR8/ACTOR10 | Patients who received ACL ACTOR8/ACTOR10 ligament, 64 patients | |
| PCL PC60/PC80 | Patients who received PCL PC60/PC80 ligament, 39 patients | |
| PCL ACTOR8/ACTOR10 | Patients who received PCL ACTOR8/ACTOR10 ligament, 39 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device failure proportion
The primary safety endpoint is the proportion of knees with a device failure at 10 years post-procedure. Device failure is defined as implant removal for any aseptic reason, including implant rupture.
Measured: 10 years
Secondary outcomes (6)
Occurence of knee-related adverse events
Perioperative and postoperative related to ligaments or fixations or instruments up to 10 years postoperatively. Occurence by % on the total number of ligaments assessed.
Measured: 10 years
Occurence of device deficiency
Description of device deficiencies occurring within 10 years post-procedure, related to the ligament reconstruction and/or fixation devices. Occurence by % on the total number of ligaments assessed.
Measured: 10 years
Occurence of reintervention
Description of reintervention occurring within 10 years post-procedure, related to any cause, without device removal. Occurence by % on the total number of ligaments assessed.
Measured: 10 years
Pain level
Pain level at 10 years measured by Knee injury and Osteoarthritis Outcome Score (KOOS) with pain subscore. It is composed on 9 questions. Each item is evaluated on 4 points ranking from 0 (none pain) to 4 (extreme pain)
Measured: 10 years
Knee function
Knee stability at 10 years measured with Lysholm score and International Knee Documentation Committee (IKDC) score .
IKDC from 0 (unable to perform activity) to 4 (very demanding activity). Lysholm score is composed of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability) IKDC 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: 10 years
Knee stability
Knee stability at 10 years measured with Lysholm score section 4 and International Knee Documentation Committee (IKDC) score section 7.
IKDC question 7 assess activity level with a 4 points item ranking from 0 (unable to perform activity) to 4 (very demanding activity).
Lysholm score section 4 assess knee stability on a 25 points item ranking from 0 (my knee gives way at every step )to 25 (my knee rarely gives way)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Ligament InjuryStudies 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
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MOVMEDIX
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- nexialist, 1Med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864337
- Sponsor's protocol ID
- RESTORE-10
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of LARS® Ligaments Associated to Fixations in Acute or Chronic Injury of the Anterior Cruciate Ligament (ACL), Posterior Cruciate (PCL) or Medial Collateral (MCL) Ligaments of the Knee
- ClinicalTrials.gov ID
- NCT07864337
- Acronym / sponsor ID
- RESTORE-10
- Conditions
- Knee Ligament Injury
- Keywords
- LARS® ligament, Artificial knee ligament
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- MOVMEDIXIndustry (pharma, biotech, devices)
- Collaborators
- nexialist, 1Med
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (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.
This study aims to assess the long-term safety, stability, knee function, pain, and satisfaction of patients who received a LARS® ligament to treat an injury of one of the main ligaments of the knee.
Detailed description
This is a multicenter observational PMCF study combining retrospective collection of historical clinical data with a prospective 10-year follow-up assessment, including a evaluation of device status, patient-reported outcomes and knee stability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MCL32 | – | –Patients who received MCL32 ligament, 51 patients |
| ACL AC30DB/AC60DB | – | –Patients who received ACL AC30DB/AC60DB ligament, 64 patients |
| ACL ACTOR8/ACTOR10 | – | –Patients who received ACL ACTOR8/ACTOR10 ligament, 64 patients |
| PCL PC60/PC80 | – | –Patients who received PCL PC60/PC80 ligament, 39 patients |
| PCL ACTOR8/ACTOR10 | – | –Patients who received PCL ACTOR8/ACTOR10 ligament, 39 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patient who underwent ligamentoplasty in 1 Knee (1leg) using one or more LARS® artificial ligaments, with or without associated fixation devices between 2015 and 2018.
Key inclusion criteria (4 listed)
- Patient who received study information and provided informed consent to participate in the study, where required by applicable local regulations and ethics committee requirements.
- Patient who underwent ligamentoplasty using one or more LARS® artificial ligaments for posterior cruciate ligament (PCL), anterior cruciate ligament (ACL), and/or medial collateral ligament (MCL) in only 1 leg (knee) reconstruction between 2015 and 2018 (or since 9 to 12 years from data collection time-point).
- Surgical procedure performed using LARS® ligaments in accordance with the intended use and routine clinical practice.
- Availability of adequate medical records and follow-up documentation allowing assessment of the study endpoints related to safety and performance
Key exclusion criteria (6 listed)
- Patients aged less than 18 years at the time of the ligamentoplasty procedure.
- Patients presenting, at the date of surgery, with any contraindication to ligamentoplasty procedures and/or contraindications specified in the applicable Instructions for Use (IFU) of the implanted device.
- Patients who are lost to follow-up, deceased at the time of study conduct.
- Patients who have undergone bilateral ligamentoplasty.
- Patients belonging to a protected or vulnerable population, including individuals under guardianship, curatorship, legal protection measures, or any other condition limiting their ability to provide informed consent in accordance with applicable local regulations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device failure proportion
Time frame: 10 years
The primary safety endpoint is the proportion of knees with a device failure at 10 years post-procedure. Device failure is defined as implant removal for any aseptic reason, including implant rupture.
6 secondary outcomes
Occurence of knee-related adverse events
Time frame: 10 years
Occurence of device deficiency
Time frame: 10 years
Occurence of reintervention
Time frame: 10 years
Pain level
Time frame: 10 years
Knee function
Time frame: 10 years
Knee stability
Time frame: 10 years
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 7 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Ligament Injury, run by MOVMEDIX.
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 4 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Device failure proportion (time frame: 10 years). 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 7 Oct 2026.