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NCT Number: NCT07538141

The Hyalex MTP Study

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.

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Key information

Conditions

Hallux Valgus Arthritis Foot Deformities Foot Deformities, Acquired Foot Injuries Hallux Limitus Hallux Rigidus Joint Diseases Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SPORTO

Lodz, Poland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTP Hemiarthroplasty

Device

Implant

Primary outcomes

  1. Freedom from implant rejection, infection

    Time frame: Through 12 months

    Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant

  2. Improvement in VAS pain

    Time frame: 12 months

    VAS pain improvement over time

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Cain

CONTACT

[email protected]

14084395154

Sponsors and collaborators

Lead sponsor

Hyalex Orthopaedics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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