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

Novastep

Status: Enrolling

Conditions: Bone Alignment Defaults; Arthritis Foot

Treatments: Device: Intervention with Lync device.

Study type: Interventional

Funder types: Industry

Identifiers

NCT06888934

2024-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Intervention with Lync device

Experimental group

Description:

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.

Treatment:

Device: Intervention with Lync device.