Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
Novastep
76 participants
Nov 4, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria10
- 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 Criteria3
- 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
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Interventions
Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06888934