Menu
Recruiting NCT07538141

The Hyalex MTP Study

No phase Interventional Hallux Valgus Hallux Limitus Hallux Rigidus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MTP Hemiarthroplasty.
Who it may be relevant to
Registry conditions: Hallux Valgus, Hallux Limitus, Hallux Rigidus. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device MTP Hemiarthroplasty
    Implant

Primary outcome measures

  • Freedom from implant rejection, infection [Time frame: Through 12 months]
  • Improvement in VAS pain [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 1 center
  • SPORTO — Lodz

Identifiers

NCT: NCT07538141 · CL-00004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗