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

NCT06888934 | Recruiting

• 1 other identifier: 2024-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

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.

Conditions

Arthritis Foot; Bone Alignment Defaults

Outcome Measures

Primary Outcomes (1)

• EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score

  Score of functional capacities of the forefoot at 3-4 post-operative months thanks to EFAS score (EUROPEAN FOOT AND ANKLE SOCIETY score : quality of life questionnaire). This six-item scale measures pain and physical function. The maximum score is 24 points (best possible) and the minimum score is 0 poins (worst possible).

  3 to 4 post-operative months

Secondary Outcomes (3)

• VAS (Visual Analogue Scale) pain score

  3 to 4 post-operative months

• Bone consolidation

  3 to 4 post-operative months

• occurrence of adverse events, complications, device defects

  through study completion, an average of 6 months

Study Arms (1)

Intervention with Lync device

EXPERIMENTAL

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.

Device: Intervention with Lync device.

Interventions

Intervention with Lync device. DEVICE

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

Intervention with Lync device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novastep: lead

Study Sites (5)

Clinique Saint-Charles

Lyon, France

RECRUITING

Polyclinique du Val de Saône

Mâcon, France

RECRUITING

Centre Chirurgical ADR

Nancy, France

NOT YET RECRUITING

Clinique Mutualiste Catalane

Perpignan, France

RECRUITING

Polyclinique Lyon Nord

Rillieux-la-Pape, France

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Manon GUIGUEN

CONTACT

+33 (0) 2 59 58 31 68; manon.guiguen@novastep-ortho.com

Flora PEYRET

CONTACT

+33 (0) 2 59 58 31 68; flora.peyret@novastep-ortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 21, 2025
• Study Start: November 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)