The Hyalex MTP Study

NCT07538141 | Recruiting DMC

• 1 other identifier: CL-00004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hallux Valgus; Hallux Limitus; Hallux Rigidus

Keywords

Arthritis

Outcome Measures

Primary Outcomes (2)

• Freedom from implant rejection, infection

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

  Through 12 months

• Improvement in VAS pain

  VAS pain improvement over time

  12 months

Study Arms (1)

Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant

EXPERIMENTAL

Device: MTP Hemiarthroplasty

Interventions

MTP Hemiarthroplasty DEVICE

Implant

Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hyalex Orthopaedics, Inc.: lead

Study Sites (1)

SPORTO

Lodz, Poland

RECRUITING

MeSH Terms

Conditions

Hallux Valgus; Hallux Limitus; Hallux Rigidus; Arthritis

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Marcin Domzalski, MD

  SPORTO, Łódź, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Cain

CONTACT

14084395154; chris.cain@hyalex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

PL (1)