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

NCT ID: NCT06888934

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2027-05-01

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 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.

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 data on similar devices.

The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device on 76 cases (feet) 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 as primary endpoint.

The secondary objectives of the study are:

• To confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the reduction in patient pain during the 3-4 month postoperative visit.
• To confirm the clinical performance of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the radiographic parameters (bone consolidation) during the 3-4 month postoperative visit.
• To confirm the safety of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the occurrence of adverse events, complications and device defects at the various postoperative follow-up visits.

The secondary endpoints associated with the secondary objective are:

• The change in the VAS score will be evaluated at the postoperative visit at 3-4 months compared to that at the preoperative visit.
• The assessment of bone consolidation will be carried out at the post-operative visit at 3-4 months. An additional visit at 6 months, assessing bone union, will be carried out ifbone union has not occurred 3-4 months post-operatively, in accordance with theinvestigators' current practice.
• The collection of adverse events and defects will be done throughout the follow-up by the surgeons thanks to questioning of the patient, assessments of clinical and radiographic examinations of the foot.

Conditions

Arthritis Foot; Bone Alignment Defaults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention with Lync device

One arm in the study : treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) wwith Lync device.

Group Type: EXPERIMENTAL

Intervention with Lync device.

Intervention Type: DEVICE

Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device.

Interventions

Intervention with Lync device.

Treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) with Lync device.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novastep

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Saint-Charles

Lyon, , France

Site Status: RECRUITING

Polyclinique du Val de Saône

Mâcon, , France

Site Status: RECRUITING

Centre Chirurgical ADR

Nancy, , France

Site Status: NOT_YET_RECRUITING

Clinique Mutualiste Catalane

Perpignan, , France

Site Status: RECRUITING

Polyclinique Lyon Nord

Rillieux-la-Pape, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Manon GUIGUEN

Role: CONTACT

manon.guiguen@novastep-ortho.com

+33 (0) 2 59 58 31 68

Flora PEYRET

Role: CONTACT

flora.peyret@novastep-ortho.com

+33 (0) 2 59 58 31 68

Facility Contacts

Timothée BISSUEL

Role: primary

Prikesht MUKISH

Role: primary

Jérôme DILIGENT

Role: primary

Fabrice COLIN

Role: primary

Stéphanie VALENTIN

Role: primary

Other Identifiers

2024-1

Identifier Type: -

Identifier Source: org_study_id