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NCT Number: NCT07121790

Mg Alloy DrillPins in Hammertoe Deformity Correction

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.

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Key information

Conditions

Hammertoe Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Hammer Toe Syndrome Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At 12 weeks postoperatively

    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

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

    Time frame: At 12 weeks postoperatively

    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.

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

    Time frame: From surgery to 12 weeks postoperatively

    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.

Secondary outcomes

  1. Degree of DrillPin resorption

    Time frame: 12 and 36 months postoperatively

    The extent of implant resorption will be assessed using CT (computed tomography) imaging at 12 and 36 months postoperatively. Resorption will be classified as one of the following categories:

    • Not visible/slight
    • Partial (25-75%)
    • Complete (implant not visible)

    Each participant will be assigned to one resorption category based on imaging findings.

  2. Number of participants with radiographic evidence of subcutaneous gas formation

    Time frame: 12 and 36 months postoperatively

    Presence or absence of subcutaneous gas cavities will be assessed using CT imaging at 12 and 36 months postoperatively.

    A binary Yes/No result will be recorded per participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Holweg, Prof. Dr.

CONTACT

[email protected]

+43 316 385-0

Sponsors and collaborators

Lead sponsor

Bioretec Ltd.

Industry

Registry information

Official study title

The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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