Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync

Launched by NOVASTEP · Mar 14, 2025

Keywords

ClinConnect Summary

The "LYNC" clinical trial is studying a new device called the Lync® to help treat arthritis in the toes and correct problems with toe alignment, such as conditions known as mallet toes, claw toes, and hammer toes. The main goal is to see how effective this device is in improving foot function within 3 to 4 months after surgery. This will be measured using a specific scoring system that looks at how well the toes are working after the treatment.

If you are an adult between the ages of 65 and 74 and have toe arthritis or alignment issues, you may be eligible to participate. To join the study, you should be willing to follow your surgeon's recommendations and able to understand and sign the consent form. Participants will receive the Lync® device, and it is important to note that certain other surgeries may be performed at the same time, but there are some exclusions, such as being involved in another clinical trial or being pregnant. This study is currently recruiting participants, and it aims to provide valuable information about the safety and benefits of this new treatment option.

Gender

ALL

Eligibility 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