Actively Recruiting
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Led by Novastep · Updated on 2025-03-21
76
Participants Needed
5
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requiring treatment of arthritis and/or correction of bone alignment default in the toes (mallet toes, claw toes, hammer toes)
- Use of the Lync4 intramedullary osteosynthesis implantable medical device
- No associated surgical procedures except flexor release/tenotomy, MTP arthrolysis/extensor lengthening, tendon transfers, or 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Clinique Saint-Charles
Lyon, France
Actively Recruiting
2
Polyclinique du Val de Saône
Mâcon, France
Actively Recruiting
3
Centre Chirurgical ADR
Nancy, France
Not Yet Recruiting
4
Clinique Mutualiste Catalane
Perpignan, France
Actively Recruiting
5
Polyclinique Lyon Nord
Rillieux-la-Pape, France
Actively Recruiting
Research Team
M
Manon GUIGUEN
CONTACT
F
Flora PEYRET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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