RecruitingNot ApplicableNCT07538141

The Hyalex MTP Study

The Hyalex First-in-Human Study - A Prospective, Single-Arm, Feasibility Study of the HYALEX SLALOM MTP Hemiarthroplasty Implant

Sponsor

Hyalex Orthopaedics, Inc.

Enrollment

20 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hallux limitus Hallux Rigidus Hallux Valgus

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.

Eligibility

Min Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called MTP Hemiarthroplasty for people with hallux rigidus, hallux valgus, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMTP Hemiarthroplasty

Implant

Locations(1)

SPORTO

Lodz, Poland

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NCT07538141

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