Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• EFAS (EUROPEAN FOOT AND ANKLE SOCIETY) score — 3 to 4 post-operative months
  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).

Trial sites (5)