The Hyalex MTP Study

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07538141

Enrollment

Registered

2026-04-20

Start date

2025-10-01

Completion date

2027-12-31

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Limitus, Hallux Rigidus, Hallux Valgus

Keywords

Arthritis

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.

Interventions

DEVICEMTP Hemiarthroplasty

Implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. 21-75 years; 2. Body Mass Index (BMI) ≤ 38; 3. Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4; 4. Pre-operative VAS pain score of \>40; 5. Presence of good bone stock, without need for bone graft

Exclusion criteria

1. Known allergy to polyurethanes, bone cement, acrylic, or titanium; 2. 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; 3. Lack of 2mm of vital bone on all sides of implant site; 4. Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment; 5. Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace); 6. Bilateral degenerative or post-traumatic arthritis of the MTP joints that would require simultaneous treatment of both MTP joints; 7. Previous cheilectomy resulting in inadequate bone stock; 8. Diagnosis of gout; 9. Hallux varus to any degree or hallux valgus \>20; 10. Hyper mobility at proximal metatarsal joint; 11. Interphalangeal angle \>15

Design outcomes

Primary

Measure	Time frame	Description
Freedom from implant rejection, infection	Through 12 months	Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Improvement in VAS pain	12 months	VAS pain improvement over time

Countries

Poland

Contacts

CONTACTChris Cain

chris.cain@hyalex.com14084395154

PRINCIPAL_INVESTIGATORMarcin Domzalski, MD

SPORTO, Łódź, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026