| NCT ID | NCT07538141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hyalex Orthopaedics, Inc. |
| Condition | Hallux Valgus |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. 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
Contact & Investigator
Marcin Domzalski, MD
PRINCIPAL INVESTIGATOR
SPORTO, Łódź, Poland
Frequently Asked Questions
Who can join the NCT07538141 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Hallux Valgus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07538141 currently recruiting?
Yes, NCT07538141 is actively recruiting participants. Contact the research team at chris.cain@hyalex.com for enrollment information.
Where is the NCT07538141 trial being conducted?
This trial is being conducted at Lodz, Poland.
Who is sponsoring the NCT07538141 clinical trial?
NCT07538141 is sponsored by Hyalex Orthopaedics, Inc.. The principal investigator is Marcin Domzalski, MD at SPORTO, Łódź, Poland. The trial plans to enroll 20 participants.