Mg Alloy DrillPins in Hammertoe Deformity Correction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioretec Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pathological bone lesions (e.g., bone cysts or osteomyelitis)
Underlying diseases (kidney diseases, diabetes mellitus)
Chronic alcoholics
Severe mental illness
Trial design
Design model
Single group
Treatments tested in this trial
Implant Mg-based RemeOs™ drillpins
DeviceThis 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Hammertoe correction surgery with Mg-based DrillPinsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 postoperatively2
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 postoperatively3
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 postoperativelySecondary outcomes
1
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 postoperatively2
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 postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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