HammertoeNCT07121790
Mg Alloy DrillPins in Hammertoe Deformity Correction
A study testing Implant Mg-based RemeOs™ drillpins in people with Hammertoe and Hammer Toe Syndrome, run by Bioretec Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hammertoe, Hammer Toe Syndrome
- What is being tested?
- Implant Mg-based RemeOs™ drillpins
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Hammertoe, Hammer Toe Syndrome
- Being tested
- Implant Mg-based RemeOs™ drillpins
- Keywords
- deformity, device, Hammertoe surgery, absorbable implant, osteotomy fixation, DrillPin, RemeOs
- Medical subject headings
- Hammer Toe Syndrome, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant Mg-based RemeOs™ drillpinsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hammertoe correction surgery with Mg-based DrillPins | Experimental | Not described Receives: Device: Implant Mg-based RemeOs™ drillpins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: From surgery to 12 weeks postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 and 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HammertoeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioretec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Holweg, Prof. Dr., Principal investigator, Department of Orthopaedics and Trauma, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121790
- Sponsor's protocol ID
- 243-03-CI-01
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22381341Holweg 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.
PubMed 32553919Bostman 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.
PubMed 8913214
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07121790
- Acronym / sponsor ID
- 243-03-CI-01
- Conditions
- Hammertoe, Hammer Toe Syndrome
- Keywords
- deformity, device, Hammertoe surgery, absorbable implant, osteotomy fixation, DrillPin, RemeOs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bioretec Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hammertoe correction surgery with Mg-based DrillPins | Experimental | Device: Implant Mg-based RemeOs™ drillpins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Pathological bone lesions (e.g., bone cysts or osteomyelitis)
- Underlying diseases (kidney diseases, diabetes mellitus)
- Chronic alcoholics
- Severe mental illness
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant Mg-based RemeOs™ drillpinsThis 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. | Device | Hammertoe correction surgery with Mg-based DrillPins |
Primary outcome
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
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.
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.
2 secondary outcomes
Degree of DrillPin resorption
Time frame: 12 and 36 months postoperatively
Number of participants with radiographic evidence of subcutaneous gas formation
Time frame: 12 and 36 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Results publication: PubMed 22381341Klammer 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.
- Results publication: PubMed 32553919Holweg 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.
- Results publication: PubMed 8913214Bostman 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.
- Individual participant dataSharing planned: 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.
Related trials for Hammertoe
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Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
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RecruitingPhase 3
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Holweg, Prof. Dr. principal investigator
Department of Orthopaedics and Trauma, Medical University of Graz
Questions about this trial
What is this clinical trial studying?
A study testing Implant Mg-based RemeOs™ drillpins in people with Hammertoe and Hammer Toe Syndrome, run by Bioretec Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Holweg, Prof. Dr. (+43 316 385-0, p.holweg@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pain score <3 on the Visual Analogue Scale (VAS) (criterion of successful implantation) (time frame: At 12 weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121790, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.