RecruitingNot Applicable

The Hyalex MTP Study

Poland20 participantsStarted 2025-10-01

Plain-language 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. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.

Who can participate

Age range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from implant rejection, infection

Timeframe: Through 12 months

Improvement in VAS pain

Timeframe: 12 months

Trial details

NCT IDNCT07538141

SponsorHyalex Orthopaedics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Chris Cain

14084395154 chris.cain@hyalex.com

View on ClinicalTrials.gov More Hallux Valgus trials