Mg Alloy DrillPins in Hammertoe Deformity Correction

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

December 31, 2029

Conditions
HammertoeHammer Toe Syndrome
Interventions
DEVICE

Implant Mg-based RemeOs™ drillpins

"This is a first-in-human clinical feasibility study of a novel absorbable magnesium-zinc-calcium alloy DrillPin (RemeOs™) for internal fixation during surgical correction of hammertoe deformities in adult patients. The implant is investigational, not CE-marked, and represents an alternative to conventional stainless steel or titanium K-wires commonly used in toe correction surgery.~The RemeOs™ DrillPin is designed to provide mechanical stability during osteotomy healing and gradually resorbs over 2-3 years, potentially eliminating the need for secondary implant removal.~The study focuses on evaluating safety, performance, and implant resorption using standardized clinical and radiographic assessments. The DrillPin is made from the same magnesium alloy (ZX00) as the CE-marked RemeOs™ Screw, which has demonstrated clinical safety and performance in prior applications."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioretec Ltd.

INDUSTRY