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 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

Inclusion Criteria5

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 Criteria11

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;
Hallux varus to any degree or hallux valgus >20;
Hyper mobility at proximal metatarsal joint;
Interphalangeal angle >15