Dr. Gomoll is currently enrolling patients in the Hyalex EFS trial of the HYALEX® Knee Cartilage System — a new option for replacement of articular cartilage and bone of the knee femoral condyles. Several other trials (NUsurface, ReNu, Atlas, Cartistem, Agili-C, Flexion FX006) have completed enrollment and are in follow-up. To inquire about eligibility, call 646-917-7441 or schedule a consultation.
Actively enrolling trials
Hyalex EFS — HYALEX® Knee Cartilage System
Prospective, multicenter, single-arm, 2-phase Early Feasibility Study (EFS) of the HYALEX® Knee Cartilage System.
The Hyalex EFS is a prospective, open-label, single-arm trial evaluating the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment. Enrolled patients undergo implantation of the HYALEX Knee Implant.
Interested? Call 646-917-7441 or request a consultation to ask about eligibility.
Completed trials or closed to enrollment
VENUS — NUsurface® meniscus implant
The VENUS study compares the NUsurface meniscus implant to non-surgical standard-of-care treatment (physical therapy, injections, bracing). The implant is an artificial device made from polycarbonate-urethane (PCU) reinforced with ultra-high molecular weight polyethylene fibers, designed to function similarly to a natural meniscus by distributing contact pressure and joint load. Closed to enrollment; in follow-up at Brigham and Women's.
ReNu™ Knee Injection — stem-cell trial for osteoarthritis
Randomized clinical trial assessing the efficacy of the ReNu™ knee injection — a suspension made from amniotic membrane and amniotic fluid stem cells — for symptomatic knee osteoarthritis. Patients were randomized to stem-cell injection, joint-lubrication injection (Monovisc, high-molecular-weight hyaluronan), or saline (placebo). Patients whose pain did not improve at 3 months without active treatment could cross over to ReNu™. One-year follow-up. Trial complete.
Atlas Knee System
Trial assessing the Atlas Knee System for symptomatic medial-compartment knee osteoarthritis. The Atlas system is designed to absorb excess joint load in the diseased medial compartment via a central spring component, with the goal of reducing pain, improving function, and delaying knee replacement in young, active, arthritic patients. Closed to enrollment; in follow-up at Brigham and Women's.
Cartistem® — umbilical cord-blood stem cells
Phase I/IIa trial investigating implantation of human umbilical cord blood-derived mesenchymal stem cells with sodium hyaluronate to regenerate cartilage and reduce pain. Trial complete.
Agili-C™ vs. Surgical Standard of Care
Prospective multicenter open-label randomized trial comparing the Agili-C™ implant to surgical standard of care (microfracture or debridement) for joint surface lesions of the knee. The implant has two components: a coral-based cylinder placed onto bone, and a hyaluronic acid liquid layer on top. Both are absorbed and replaced by new tissue over time. Closed for enrollment.
Flexion FX006 (Zilretta®) — extended-release triamcinolone
Trial of the safety and tolerability of repeat administration (two doses of 40 mg) of FX006 — an extended-release formulation of triamcinolone acetonide — for symptomatic knee osteoarthritis.
Inquire about a trial
To find out if you are eligible for any of Dr. Gomoll's open trials, call our office or request a consultation:
Call 646-917-7441 Request a Consultation
Several of these studies evaluate regenerative medicine and stem-cell therapies. For background on Dr. Gomoll's publications and research credentials, visit those pages.