Status:
RECRUITING
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Lead Sponsor:
Novastep
Conditions:
Arthritis Foot
Bone Alignment Defaults
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mis...
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 da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06888934
Start Date
November 4 2024
End Date
May 1 2027
Last Update
March 21 2025
Active Locations (5)
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1
Clinique Saint-Charles
Lyon, France
2
Polyclinique du Val de Saône
Mâcon, France
3
Centre Chirurgical ADR
Nancy, France
4
Clinique Mutualiste Catalane
Perpignan, France