The Hyalex MTP Study
Recruiting
N/A
Interventional Study
Hallux Valgus
Hallux Limitus
Hallux Rigidus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 21 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Hyalex Orthopaedics, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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. Know…
Contacts