Mg Alloy DrillPins in Hammertoe Deformity Correction

NCT ID: NCT07121790

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-12-31

Brief 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.

Detailed Description

This single-arm, open-label, monocenter clinical investigation is conducted in accordance with ISO 14155 to evaluate the safety and performance of the RemeOs™ DrillPin, an absorbable magnesium-zinc-calcium alloy (ZX00) implant, for internal fixation during hammertoe correction surgery in adult patients.

Eligible participants are adults aged 18 years and older with hammertoe deformity of the lesser toes requiring surgical correction, with or without concomitant hallux valgus surgery. The RemeOs™ DrillPin is designed to provide mechanical stability during osteotomy healing and gradually resorbs over time, potentially eliminating the need for implant removal and reducing infection risk through primary wound closure.

Primary objectives include assessing implantation success-defined as low pain levels (VAS <3) and good or fair toe alignment according to the AOFAS Lesser Metatarsophalangeal-Interphalangeal Scale (AOFAS-LMIS)-at 12 weeks postoperatively, as well as short-term safety, measured by the incidence of adverse and serious adverse device events (ADEs/SADEs).

Secondary assessments include clinical evaluation of pain, wound healing, DIP joint function, and neurovascular status at 2, 4, 6, and 12 weeks, and at 12 and 36 months. Radiographic assessments will monitor alignment, gas formation, and osteolysis at each follow-up, with CT imaging at 12 and 36 months to evaluate implant resorption and potential local effects.

This feasibility study aims to generate initial clinical data on the use of absorbable magnesium-based implants in forefoot surgery and to assess their potential to maintain deformity correction without the need for implant retrieval.

Conditions

Hammertoe; Hammer Toe Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hammertoe correction surgery with Mg-based DrillPins

Group Type: EXPERIMENTAL

Implant Mg-based RemeOs™ drillpins

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Hammertoe deformity of the lesser toes, with or without accompanying surgery of a hallux valgus deformity
• Written informed consent of the participant
• Female and male patients aged 18 years and more
• Subject has been informed of the nature of the study, agrees to participate and signs the approved consent form
• Subject is able and willing to comply with all assessments in the study.
• Female patients in childbearing age perform a pregnancy test prior to inclusion

Exclusion Criteria

• Pathological bone lesions (e.g., bone cysts or osteomyelitis)
• Underlying diseases (kidney diseases, diabetes mellitus)
• Chronic alcoholics
• Severe mental illness
• Pregnant or breastfeeding women
• Inability or unwillingness to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioretec Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Holweg, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Trauma, Medical University of Graz

Central Contacts

Patrick Holweg, Prof. Dr.

Role: CONTACT

p.holweg@medunigraz.at

+43 316 385-0

References

Klammer G, Baumann G, Moor BK, Farshad M, Espinosa N. Early complications and recurrence rates after Kirschner wire transfixion in lesser toe surgery: a prospective randomized study. Foot Ankle Int. 2012 Feb;33(2):105-12. doi: 10.3113/FAI.2012.0105.

Reference Type: RESULT

PMID: 22381341 (View on PubMed)

Holweg P, Berger L, Cihova M, Donohue N, Clement B, Schwarze U, Sommer NG, Hohenberger G, van den Beucken JJJP, Seibert F, Leithner A, Loffler JF, Weinberg AM. A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model. Acta Biomater. 2020 Sep 1;113:646-659. doi: 10.1016/j.actbio.2020.06.013. Epub 2020 Jun 14.

Reference Type: RESULT

PMID: 32553919 (View on PubMed)

Bostman O, Pihlajamaki H. Routine implant removal after fracture surgery: a potentially reducible consumer of hospital resources in trauma units. J Trauma. 1996 Nov;41(5):846-9. doi: 10.1097/00005373-199611000-00013.

Reference Type: RESULT

PMID: 8913214 (View on PubMed)

Other Identifiers

243-03-CI-01

Identifier Type: -

Identifier Source: org_study_id