Hallux ValgusNCT07538141
The Hyalex MTP Study
A study testing MTP Hemiarthroplasty in people with Hallux Valgus and Hallux Limitus, run by Hyalex Orthopaedics, Inc. at 1 site in Poland.
Trial summary
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hallux Valgus, Hallux Limitus, Hallux Rigidus
- What is being tested?
- MTP Hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2025to 31 May 2027
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-75 years;
- Body Mass Index (BMI) ≤ 38;
- Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4;
- Pre-operative VAS pain score of >40;
- Presence of good bone stock, without need for bone graft
Who cannot join
- Known allergy to polyurethanes, bone cement, acrylic, or titanium;
- Due to anatomy and/or lesion location, inability to position the implant flush or slightly proud relative to the articular surface precluding proper device placement;
- Lack of 2mm of vital bone on all sides of implant site;
- Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment;
- Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace);
- Bilateral degenerative or post-traumatic arthritis of the MTP joints that would require simultaneous treatment of both MTP joints;
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- Previous cheilectomy resulting in inadequate bone stock;
- Diagnosis of gout;
- Hallux varus to any degree or hallux valgus >20;
- Hyper mobility at proximal metatarsal joint;
- Interphalangeal angle >15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hyalex First-in-Human Study - A Prospective, Single-Arm, Feasibility Study of the HYALEX SLALOM MTP Hemiarthroplasty Implant
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.
- Conditions
- Hallux Valgus, Hallux Limitus, Hallux Rigidus
- Being tested
- MTP Hemiarthroplasty
- Keywords
- Arthritis
- Medical subject headings
- Hallux Valgus, Hallux Limitus, Hallux Rigidus, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP HemiarthroplastyDevice
Implant
| Study group | Role | What they receive |
|---|---|---|
| Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant | Experimental | Not described Receives: Device: MTP Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from implant rejection, infection
Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Measured: Through 12 months
Improvement in VAS pain
VAS pain improvement over time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Oct 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyalex Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcin Domzalski, MD, Principal investigator, SPORTO, Łódź, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538141
- Sponsor's protocol ID
- CL-00004
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hyalex First-in-Human Study - A Prospective, Single-Arm, Feasibility Study of the HYALEX SLALOM MTP Hemiarthroplasty Implant
- ClinicalTrials.gov ID
- NCT07538141
- Acronym / sponsor ID
- CL-00004
- Conditions
- Hallux Valgus, Hallux Limitus, Hallux Rigidus
- Keywords
- Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hyalex Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant | Experimental | Device: MTP Hemiarthroplasty |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21-75 years;
- Body Mass Index (BMI) ≤ 38;
- Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4;
- Pre-operative VAS pain score of >40;
- Presence of good bone stock, without need for bone graft
Key exclusion criteria (11 listed)
- Known allergy to polyurethanes, bone cement, acrylic, or titanium;
- Due to anatomy and/or lesion location, inability to position the implant flush or slightly proud relative to the articular surface precluding proper device placement;
- Lack of 2mm of vital bone on all sides of implant site;
- Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment;
- Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace);
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 |
|---|---|---|
| MTP HemiarthroplastyImplant | Device | Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant |
Primary outcome
Freedom from implant rejection, infection
Time frame: Through 12 months
Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Improvement in VAS pain
Time frame: 12 months
VAS pain improvement over time
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 7 Oct 2026.
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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. This study is not recruiting at the moment.
Marcin Domzalski, MD principal investigator
SPORTO, Łódź, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTP Hemiarthroplasty in people with Hallux Valgus and Hallux Limitus, run by Hyalex Orthopaedics, Inc. at 1 site in Poland.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from implant rejection, infection (time frame: Through 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.