Knee Ligament InjuryNCT04122677
Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions
An observational study of Knee Ligament Injury, run by Biomatlante at 1 site in France.
Trial summary
The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Ligament Injury
- What is being tested?
- Anterior Cruciate Ligament Reconstruction
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2019to 21 Dec 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria. The study population is composed of 56 patients according to the protocol.
Who may be able to join
- Acute or chronic Anterior Cruciate Ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
- Males or females aged from 18 to 60 years
- No history of surgery on the affected knee
- Patients not under guardianship or judicial protection
- Signature of non opposition form (consent of the patient
Who cannot join
- History of ligament, meniscal surgery or fracture of the affected knee
- Pregnancy of breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site
Centre ORTHEO
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42100
About this study
The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:
Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery
- Conditions
- Knee Ligament Injury
- Being tested
- Anterior Cruciate Ligament Reconstruction
- Keywords
- Knee Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Knee Ligament Rupture, Knee Ligament Reconstruction
- 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.
Anterior Cruciate Ligament ReconstructionDevice
Reconstruction of the Anterior Cruciate Ligament using an interference screw.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the objective International Knee Documentation Committee score before and after surgery
Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal)
Measured: 4 months before surgery / 7 months post-surgery
Change of the subjective International Knee Documentation Committee score before and after surgery
Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)
Measured: 4 months before surgery / 7 months post-surgery
Secondary outcomes (2)
Number and precise description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the Polylactic Interference Screw
Measured: Before surgery until 7 months post-surgery
Change in the patients recovery
Record of specific items of the Objective International Knee Documentation Committee score reflecting the patients recovery
Measured: 2 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start14 Nov 2019
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomatlante
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Responsible party
- Sponsor
- Investigators
- François-Xavier FV VERDOT, M.D., Principal investigator, Centre ORTHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122677
- Sponsor's protocol ID
- 2018-A03207-48
- Status last verified
- Feb 2025
- First submitted
- 30 Sep 2019
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions
- ClinicalTrials.gov ID
- NCT04122677
- Acronym / sponsor ID
- 2018-A03207-48
- Conditions
- Knee Ligament Injury
- Keywords
- Knee Ligament Injury, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Knee Ligament Rupture, Knee Ligament Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BiomatlanteIndustry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 10 Oct 2019 (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 evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:
Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria. The study population is composed of 56 patients according to the protocol.
Key inclusion criteria (5 listed)
- Acute or chronic Anterior Cruciate Ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
- Males or females aged from 18 to 60 years
- No history of surgery on the affected knee
- Patients not under guardianship or judicial protection
- Signature of non opposition form (consent of the patient
Key exclusion criteria (2 listed)
- History of ligament, meniscal surgery or fracture of the affected knee
- Pregnancy of breastfeeding women
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 using an interference screw. | Device | – |
Primary outcome
Change of the objective International Knee Documentation Committee score before and after surgery
Time frame: 4 months before surgery / 7 months post-surgery
Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal)
Change of the subjective International Knee Documentation Committee score before and after surgery
Time frame: 4 months before surgery / 7 months post-surgery
Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)
2 secondary outcomes
Number and precise description of any adverse event during the follow-up
Time frame: Before surgery until 7 months post-surgery
Change in the patients recovery
Time frame: 2 months post-surgery
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 4 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Ligament Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
François-Xavier FV VERDOT, M.D. principal investigator
Centre ORTHEO
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 Knee Ligament Injury, run by Biomatlante at 1 site in France.
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 2 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 4 Feb 2025. 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 France. 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?
Change of the objective International Knee Documentation Committee score before and after surgery (time frame: 4 months before surgery / 7 months post-surgery). The study lists 2 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 4 Feb 2025.