The Hyalex MTP Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorHyalex Orthopaedics, Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
MTP Hemiarthroplasty
DeviceImplant
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Implantation of HYALEX SLALOM MTP Hemiarthroplasty ImplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from implant rejection, infection
Assess the safety and performance of the HYALEX SLALOM MTP Hemiarthroplasty Implant
Time frame
Through 12 months2
Improvement in VAS pain
VAS pain improvement over time
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov