Treatment of arthritis and toe bone alignment issues with the Lync device
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
This study is testing if the Lync device can help people with arthritis and toe bone alignment problems feel better and regain foot function after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novastep Industry-sponsored |
| Locations | 5 sites (Lyon and 4 other locations) |
| Trial ID | NCT06888934 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness, safety, and performance of the Lync® device when implanted in the toes to treat arthritis and correct bone alignment issues. The study aims to assess the restoration of functional capacities of the forefoot at 3-4 months post-operation using the AOFAS-LMIS score as the primary endpoint. Secondary objectives include measuring pain reduction and evaluating radiographic parameters for bone consolidation. The study will involve 76 cases and will monitor for any adverse events or complications.
Who should consider this trial
Good fit: Ideal candidates are adults requiring treatment for arthritis or correction of bone alignment issues in the toes.
Not a fit: Patients with contraindications to the Lync device or those involved in other clinical investigations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from arthritis and toe misalignments.
How similar studies have performed: This approach is novel and has not been previously covered by clinical data on similar devices.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * MTP Arthrolysis / Extensor Lengthening * Tendon transfers * Phalangeal osteotomy * 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: * 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
Where this trial is running
Lyon and 4 other locations
- Clinique Saint-Charles — Lyon, France (Recruiting)
- Polyclinique du Val de Saône — Mâcon, France (Recruiting)
- Centre Chirurgical ADR — Nancy, France (Not_yet_recruiting)
- Clinique Mutualiste Catalane — Perpignan, France (Recruiting)
- Polyclinique Lyon Nord — Rillieux-la-Pape, France (Recruiting)
Study contacts
- Study coordinator: Manon GUIGUEN
- Email: manon.guiguen@novastep-ortho.com
- Phone: +33 (0) 2 59 58 31 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.