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Active, not recruitingNCT07538141Updated Oct 7, 2026

The Hyalex MTP Study

An interventional study of MTP Hemiarthroplasty in Hallux Valgus, Hallux Limitus and Hallux Rigidus, sponsored by Hyalex Orthopaedics, Inc.. Active, not recruiting at 1 site in Poland. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Hyalex Orthopaedics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2025, registered Apr 2026).
Updated Oct 7, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hallux Valgus
  • Hallux Limitus
  • Hallux Rigidus

Keywords

  • Arthritis
03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 20 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Hyalex Orthopaedics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 21-75 years;
  2. (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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant

    Device: MTP Hemiarthroplasty

Interventions

  • DeviceMTP Hemiarthroplasty

    Implant

06

What researchers measure

Primary outcomes

  1. Freedom from implant rejection, infection

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

    Time frame: Through 12 months

  2. Improvement in VAS pain

    VAS pain improvement over time

    Time frame: 12 months

07

Study locations

1 site
  • SPORTO
    Lodz, Poland
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 7, 2026
Primary completion
Dec 31, 2027→May 31, 2027
Oct 7, 2026
Study completion
Dec 31, 2027→May 31, 2027
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Recruiting→Active, not recruiting
    Primary completion Dec 31, 2027→May 31, 2027
    Study completion Dec 31, 2027→May 31, 2027
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07538141
Lead sponsor
Hyalex Orthopaedics, Inc.
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Oct 1, 2025
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Marcin Domzalski, MD
principal investigator · SPORTO, Łódź, Poland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Hallux Valgus →

Other studies from this sponsor

Hyalex Orthopaedics, Inc.

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