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
Qualifiers
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
Treatments tested in this trial
- Implant Mg-based RemeOs™ drillpins
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov