The Hyalex MTP Study

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.

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