Actively Recruiting
The Hyalex MTP Study
Led by Hyalex Orthopaedics, Inc. · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Hyalex MTP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 75 years
- Body Mass Index (BMI) of 38 or less
- Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4
- Pre-operative Visual Analog Scale (VAS) pain score greater than 40
- Presence of good bone stock without need for bone graft
You will not qualify if you...
- Known allergy to polyurethanes, bone cement, acrylic, or titanium
- Inability to position the implant flush or slightly proud relative to the articular surface due to anatomy or lesion location
- Lack of at least 2mm of vital bone on all sides of the implant site
- Cartilage lesions of ICRS Grade 3 or 4 on the phalanx opposite the intended treatment lesion
- Additional ipsilateral lower limb pathology requiring active treatment such as surgery or brace
- Bilateral degenerative or post-traumatic arthritis of the MTP joints needing simultaneous treatment
- Previous cheilectomy resulting in inadequate bone stock
- Diagnosis of gout
- Presence of hallux varus of any degree or hallux valgus greater than 20 degrees
- Hyper mobility at the proximal metatarsal joint
- Interphalangeal angle greater than 15 degrees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SPORTO
Lodz, Poland
Actively Recruiting
Research Team
C
Chris Cain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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