The Hyalex MTP Study

Recruiting now · Not applicable

Conditions studied: Hallux Valgus, Hallux Limitus, Hallux Rigidus

In brief

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.

Key facts

Study ID

NCT07538141

Run by

Hyalex Orthopaedics, Inc.

People needed

20

Starts

2025-10-01

Expected to finish

2027-12-31

Last updated by the study team

2026-04-20

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• SPORTO — Lodz, Poland (enrolling)

Full record on ClinicalTrials.gov

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