Mg Alloy DrillPins in Hammertoe Deformity Correction

NCT07121790 | Not Yet Recruiting

• 1 other identifier: 243-03-CI-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hammertoe; Hammer Toe Syndrome

Keywords

deformity; device; Hammertoe surgery; absorbable implant; osteotomy fixation; DrillPin; RemeOs

Outcome Measures

Primary Outcomes (3)

• Number of participants with pain score <3 on the Visual Analogue Scale (VAS) (criterion of successful implantation)

  This outcome is one of two predefined criteria used to determine successful implantation. Pain will be measured using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). A score of less than 3 at 12 weeks postoperatively is considered a successful pain outcome

  At 12 weeks postoperatively

• Number of participants with good or fair alignment on the AOFAS Lesser Metatarsophalangeal-Interphalangeal Scale (AOFAS-LMIS) (criterion of successful implantation)

  This is one of two predefined criteria for successful implantation. Toe alignment will be assessed at 12 weeks postoperatively using the alignment domain of the AOFAS-LMIS. In this subscale, alignment is scored as follows: 15 points: Good alignment (toe well aligned) 8 points: Fair alignment (some malalignment without symptoms) 0 points: Poor alignment (obvious symptomatic malalignment) An alignment score of 8 or 15 points is considered a successful outcome.

  At 12 weeks postoperatively

• Number of participants with at least one adverse device event (ADE) or serious adverse device event (SADE)

  This outcome measures the short-term safety of the investigational device. Safety will be assessed by recording the occurrence, type, severity, and investigator-assessed relationship of all adverse device events (ADEs) and serious adverse device events (SADEs) from surgery through 12 weeks postoperatively. Data will be collected through clinical evaluations, subject interviews, and medical record review.

  From surgery to 12 weeks postoperatively

Secondary Outcomes (2)

• Degree of DrillPin resorption

  12 and 36 months postoperatively

• Number of participants with radiographic evidence of subcutaneous gas formation

  12 and 36 months postoperatively

Study Arms (1)

Hammertoe correction surgery with Mg-based DrillPins

EXPERIMENTAL

Device: Implant Mg-based RemeOs™ drillpins

Interventions

Implant Mg-based RemeOs™ drillpins 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.

Hammertoe correction surgery with Mg-based DrillPins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioretec Ltd.: lead

Related Publications (3)

• 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.

  PMID: 22381341 RESULT

• 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.

  PMID: 32553919 RESULT

• 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.

  PMID: 8913214 RESULT

MeSH Terms

Conditions

Hammer Toe Syndrome; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patrick Holweg, Prof. Dr.

  Department of Orthopaedics and Trauma, Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Holweg, Prof. Dr.

CONTACT

+43 316 385-0; p.holweg@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm interventional study in which all enrolled participants receive the investigational device, the RemeOs™ DrillPin, for surgical correction of hammertoe deformities. All patients are followed using a standardized clinical and radiographic assessment schedule.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share