BridgeMD
New treatment option for Hallux Valgus
Official title The Hyalex MTP Study
ClinicalTrials.gov ID: NCT07538141
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join 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 likely can't join 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...
- 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;
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lodz, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lodz, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.