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 range21 Years – 75 Years

SexALL

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;
✕. 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;
✕. Previous cheilectomy resulting in inadequate bone stock;
✕. Diagnosis of gout;

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