An interventional study of Implant Mg-based RemeOs™ drillpins in Hammertoe and Hammer Toe Syndrome, sponsored by Bioretec Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Bioretec Ltd. · Not applicable, Interventional, and Treatment
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.
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.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: From surgery to 12 weeks postoperatively
Degree of DrillPin resorption
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.
Time frame: 12 and 36 months postoperatively
Number of participants with radiographic evidence of subcutaneous gas formation
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.
Time frame: 12 and 36 months postoperatively
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared. The study data are pseudonymized and retained only by the investigator site with no access to direct identifiers by the sponsor. The sponsor only receives pseudonymized data for analysis and regulatory use.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Bioretec Ltd.