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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 to 4 post-operative months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 to 4 post-operative months |
| Bone consolidation |
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Inclusion Criteria:
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,
Patient able to read and understand the information note and the consent form,
Patient able to sign a consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon GUIGUEN | Contact | +33 (0) 2 59 58 31 68 | manon.guiguen@novastep-ortho.com | |
| Flora PEYRET | Contact | +33 (0) 2 59 58 31 68 | flora.peyret@novastep-ortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint-Charles | Recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Radiographic parameters: bone consolidation or no bone consolidation according to the surgeon, at 3-4 post-operative months. |
| 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) | through study completion, an average of 6 months |
| Polyclinique du Val de Saône | Recruiting | Mâcon | France |
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| Centre Chirurgical ADR | Not yet recruiting | Nancy | France |
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| Clinique Mutualiste Catalane | Recruiting | Perpignan | France |
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| Polyclinique Lyon Nord | Recruiting | Rillieux-la-Pape | France |
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