Clinical trial NCT06888934: Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Official title: Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Foot
Bone Alignment Defaults
Lead sponsor: Novastep
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score
timeFrame: 3 to 4 post-operative months
Secondary outcomes:
measure: VAS (Visual Analogue Scale) pain score
timeFrame: 3 to 4 post-operative months
measure: Bone consolidation
timeFrame: 3 to 4 post-operative months
measure: occurrence of adverse events, complications, device defects
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique Saint-Charles
city: Mâcon
country: France
facility: Polyclinique du Val de Saône
city: Nancy
country: France
facility: Centre Chirurgical ADR
city: Perpignan
country: France
facility: Clinique Mutualiste Catalane
city: Rillieux-la-Pape
country: France
facility: Polyclinique Lyon Nord
Study officials:
References: