Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention with Lync device..
- Who it may be relevant to
- Registry conditions: Arthritis Foot, Bone Alignment Defaults. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
Overview
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.
Interventions
- 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.
Primary outcome measures
- EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score [Time frame: 3 to 4 post-operative months]
Secondary outcome measures (3)
- VAS (Visual Analogue Scale) pain score [Time frame: 3 to 4 post-operative months]
- Bone consolidation [Time frame: 3 to 4 post-operative months]
- occurrence of adverse events, complications, device defects [Time frame: through study completion, an average of 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 5 centers
- Clinique Saint-Charles — Lyon
- Polyclinique du Val de Saône — Mâcon
- Centre Chirurgical ADR — Nancy
- Clinique Mutualiste Catalane — Perpignan
- Polyclinique Lyon Nord — Rillieux-la-Pape
Identifiers
NCT: NCT06888934 · 2024-1