Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-01-01 @ 5:48 AM
Study NCT ID:
NCT06888934
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync
Sponsor:
Novastep
Organization:
Study Overview
Official Title:
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LYNC
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: