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New toe implant aims to ease arthritis pain without fusion

NCT ID NCT07538141

Disease control Sponsor: Hyalex Orthopaedics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new synthetic implant for the big toe joint in people with arthritis. The implant replaces the damaged joint surface to reduce pain and improve function. About 20 adults aged 21-75 with moderate to severe arthritis will be enrolled and followed for safety and pain relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 21-75 years; 2. Body Mass Index (BMI) ≤ 38; 3. Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4; 4. Pre-operative VAS pain score of \>40; 5. Presence of good bone stock, without need for bone graft Exclusion Criteria: 1. Known allergy to polyurethanes, bone cement, acrylic, or titanium; 2. 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; 3. Lack of 2mm of vital bone on all sides of implant site; 4. Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment; 5. Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace); 6. Bilateral degenerative or post-traumatic arthritis of the MTP joints that would require simultaneous treatment of both MTP joints; 7. Previous cheilectomy resulting in inadequate bone stock; 8. Diagnosis of gout; 9. Hallux varus to any degree or hallux valgus \>20; 10. Hyper mobility at proximal metatarsal joint; 11. Interphalangeal angle \>15

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Conditions

The condition(s) this trial relates to.

arthritic joint disease Hallux Limitus Hallux Rigidus Hallux Valgus osteoarthritis, toe

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hallux limitus Hallux rigidus Hallux valgus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SPORTO

    RECRUITING

    Lodz, Poland

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