An interventional study of Intervention with Lync device. in Arthritis Foot and Bone Alignment Defaults, sponsored by Novastep. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Novastep (part of Enovis) · Not applicable, Interventional, and Other
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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.
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:
The secondary endpoints associated with the secondary objective are:
Novastep is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
First submitted after Novastep became part of Enovis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
No associated surgical procedures except:▪Flexor release/tenotomy
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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).
Time frame: 3 to 4 post-operative months
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).
Time frame: 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.
Time frame: 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)
Time frame: through study completion, an average of 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for May 2027, 29 months after the start.
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