Arthritis FootLYNCNCT06888934
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
A study testing Intervention with Lync device. in people with Arthritis Foot and Bone Alignment Defaults, run by Novastep at 5 sites in France.
Trial summary
The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis and correction of bone misalignments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Foot, Bone Alignment Defaults
- What is being tested?
- Intervention with Lync device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Nov 2024to 1 May 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient requiring treatment of arthritis and/or correction of bone alignement defaultin the toes (mallet toes, claw toes, hammer toes),
- Use of the Lync® intramedullary osteosynthesis implantable medical device,
- No associated surgical procedures except:▪Flexor release/tenotomy
- MTP Arthrolysis / Extensor Lengthening
- Tendon transfers
- Phalangeal osteotomy
Show all 10Show fewer
- Adult patient,
- Patient capable of respecting the prescriptions and recommendations of his surgeon,
- Patient able to read and understand the information note and the consent form,
- Patient able to sign a consent form.
Who cannot join
- Patient presenting a contraindication to the device under investigation;
- Simultaneous participation in another clinical investigation protocol;
- Adults subject to legal protection (judicial protection, curatorship, guardianship),persons deprived of their liberty, pregnant or breastfeeding women, minors
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Clinique Saint-Charles
Lyon
Timothée BISSUEL
Romain AUGOYARD
- Recruiting
Polyclinique du Val de Saône
Mâcon
Prikesht MUKISH
Prikesht MUKISH
- Not yet recruiting
Centre Chirurgical ADR
Nancy
Jérôme DILIGENT
Jérôme DILIGENT
- Recruiting
Clinique Mutualiste Catalane
Perpignan
Fabrice COLIN
Fabrice COLIN
- Recruiting
Polyclinique Lyon Nord
Rillieux-la-Pape
Stéphanie VALENTIN
Stéphanie VALENTIN
About this study
Official title: Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis and correction of bone misalignments.
The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score.
Read the detailed description
The clinical evaluation demonstrates that the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis are not covered by any clinical data on similar devices.
The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device on 76 cases (feet) when implanted in the toes for the treatment of arthritis and correction of bone misalignments.
The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score as primary endpoint.
The secondary objectives of the study are:
- To confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the reduction in patient pain during the 3-4 month postoperative visit.
- To confirm the clinical performance of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the radiographic parameters (bone consolidation) during the 3-4 month postoperative visit.
- To confirm the safety of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the occurrence of adverse events, complications and device defects at the various postoperative follow-up visits.
The secondary endpoints associated with the secondary objective are:
- The change in the VAS score will be evaluated at the postoperative visit at 3-4 months compared to that at the preoperative visit.
- The assessment of bone consolidation will be carried out at the post-operative visit at 3-4 months. An additional visit at 6 months, assessing bone union, will be carried out ifbone union has not occurred 3-4 months post-operatively, in accordance with theinvestigators' current practice.
- The collection of adverse events and defects will be done throughout the follow-up by the surgeons thanks to questioning of the patient, assessments of clinical and radiographic examinations of the foot.
- Conditions
- Arthritis Foot, Bone Alignment Defaults
- Being tested
- Intervention with Lync device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with Lync device.Device
Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with Lync device | Experimental | One arm in the study : treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) wwith Lync device. Receives: Device: Intervention with Lync device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score
Score of functional capacities of the forefoot at 3-4 post-operative months thanks to EFAS score (EUROPEAN FOOT AND ANKLE SOCIETY score : quality of life questionnaire). This six-item scale measures pain and physical function.
The maximum score is 24 points (best possible) and the minimum score is 0 poins (worst possible).
Measured: 3 to 4 post-operative months
Secondary outcomes (3)
VAS (Visual Analogue Scale) pain score
Reduction in patient pain with VAS pain score (Visual Analogue Scale for pain) at 3-4 post-operative months.
The maximum score is 10 points (maximum pain) and the minimum score is 0 poins (minimal pain).
Measured: 3 to 4 post-operative months
Bone consolidation
Radiographic parameters: bone consolidation or no bone consolidation according to the surgeon, at 3-4 post-operative months.
Measured: 3 to 4 post-operative months
occurrence of adverse events, complications, device defects
Safety evaluated with occurrence (number and description) of adverse events, complications and device defects throughout the study (maximum 6 post-operative months)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start4 Nov 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis FootStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novastep
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888934
- Sponsor's protocol ID
- 2024-1
- Acronym
- LYNC
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 21 Mar 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
- ClinicalTrials.gov ID
- NCT06888934
- Acronym / sponsor ID
- LYNC / 2024-1
- Conditions
- Arthritis Foot, Bone Alignment Defaults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- NovastepIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 21 Mar 2025 (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 "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis and correction of bone misalignments.
The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score.
Detailed description
The clinical evaluation demonstrates that the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis are not covered by any clinical data on similar devices.
The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device on 76 cases (feet) when implanted in the toes for the treatment of arthritis and correction of bone misalignments.
The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score as primary endpoint.
The secondary objectives of the study are:
- To confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the reduction in patient pain during the 3-4 month postoperative visit.
- To confirm the clinical performance of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the radiographic parameters (bone consolidation) during the 3-4 month postoperative visit.
- To confirm the safety of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the occurrence of adverse events, complications and device defects at the various postoperative follow-up visits.
The secondary endpoints associated with the secondary objective are:
- The change in the VAS score will be evaluated at the postoperative visit at 3-4 months compared to that at the preoperative visit.
- The assessment of bone consolidation will be carried out at the post-operative visit at 3-4 months. An additional visit at 6 months, assessing bone union, will be carried out ifbone union has not occurred 3-4 months post-operatively, in accordance with theinvestigators' current practice.
- The collection of adverse events and defects will be done throughout the follow-up by the surgeons thanks to questioning of the patient, assessments of clinical and radiographic examinations of the foot.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with Lync device | Experimental | Device: Intervention with Lync device.One arm in the study : treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) wwith Lync device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient requiring treatment of arthritis and/or correction of bone alignement defaultin the toes (mallet toes, claw toes, hammer toes),
- Use of the Lync® intramedullary osteosynthesis implantable medical device,
- No associated surgical procedures except:▪Flexor release/tenotomy
- Adult patient,
- Patient capable of respecting the prescriptions and recommendations of his surgeon,
Key exclusion criteria (3 listed)
- Patient presenting a contraindication to the device under investigation;
- Simultaneous participation in another clinical investigation protocol;
- Adults subject to legal protection (judicial protection, curatorship, guardianship),persons deprived of their liberty, pregnant or breastfeeding women, minors
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 |
|---|---|---|
| Intervention with Lync device.Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device. | Device | Intervention with Lync device |
Primary outcome
EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score
Time frame: 3 to 4 post-operative months
Score of functional capacities of the forefoot at 3-4 post-operative months thanks to EFAS score (EUROPEAN FOOT AND ANKLE SOCIETY score : quality of life questionnaire). This six-item scale measures pain and physical function. The maximum score is 24 points (best possible) and the minimum score is 0 poins (worst possible).
3 secondary outcomes
VAS (Visual Analogue Scale) pain score
Time frame: 3 to 4 post-operative months
Bone consolidation
Time frame: 3 to 4 post-operative months
occurrence of adverse events, complications, device defects
Time frame: through study completion, an average of 6 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 21 Mar 2025.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with Lync device. in people with Arthritis Foot and Bone Alignment Defaults, run by Novastep at 5 sites 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 10 inclusion and 3 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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 Manon GUIGUEN (+33 (0) 2 59 58 31 68, manon.guiguen@novastep-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score (time frame: 3 to 4 post-operative 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 21 Mar 2025.