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Mg Alloy DrillPins in Hammertoe Deformity Correction
Sponsor: Bioretec Ltd.
Summary
This is a prospective, single-arm clinical feasibility study evaluating the safe application of a novel lean absorbable magnesium-zinc-calcium alloy (ZX00) drill pin (RemeOs™ DrillPin) for the surgical correction of hammertoe deformities. A total of 20 adult patients will be enrolled. All participants will receive the investigational implant without a comparator or control group. The study focuses on feasibility, safety, and functional outcomes following implantation.
Official title: The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08
Completion Date
2029-12
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
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.