Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes with Lync (LYNC)

Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis Foot; Bone Alignment Defaults
• Intervention / Treatment: Device: Intervention with Lync device.

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manon GUIGUEN; Phone Number: +33 (0) 2 59 58 31 68; Email: manon.guiguen@novastep-ortho.com
• Study Contact Backup: Name: Flora PEYRET; Phone Number: +33 (0) 2 59 58 31 68; Email: flora.peyret@novastep-ortho.com

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Clinique Saint-Charles
    • Contact: Timothée BISSUEL
    • Contact: Romain AUGOYARD
    • Contact: Tristan MEUSNIER
    • Contact: Prikesht MUKISH
    • Contact: Stéphanie VALENTIN
  • Mâcon, France
    • Recruiting
    • Polyclinique du Val de Saône
    • Contact: Prikesht MUKISH
  • Nancy, France
    • Not yet recruiting
    • Centre Chirurgical ADR
    • Contact: Jérôme DILIGENT
  • Perpignan, France
    • Recruiting
    • Clinique Mutualiste Catalane
    • Contact: Fabrice COLIN
  • Rillieux-la-Pape, France
    • Recruiting
    • Polyclinique Lyon Nord
    • Contact: Stéphanie VALENTIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual Analogue Scale) pain score	Reduction in patient pain with VAS pain score (Visual Analogue Scale for pain) at 3-4 post-operative months. The maximum score is 10 points (maximum pain) and the minimum score is 0 poins (minimal pain).	3 to 4 post-operative months
Bone consolidation	Radiographic parameters: bone consolidation or no bone consolidation according to the surgeon, at 3-4 post-operative months.	3 to 4 post-operative months
occurrence of adverse events, complications, device defects	Safety evaluated with occurrence (number and description) of adverse events, complications and device defects throughout the study (maximum 6 post-operative months)	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Novastep

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: 2024-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No