Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Part of paid clinical trials in Mission Hills, California.

Sponsor
DT MedTech, LLC
Study ID
NCT04770870
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis Ankle
  • Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
  • Post-Traumatic Osteoarthritis of Ankle

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hintermann Series H3 Total Ankle Replacement System — DEVICE
    Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.

Study Details

The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.

Key Dates

Start date
Feb 1, 2022
Status verified
Jun 2024
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
232 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment Arm
    All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.

Primary Outcome Measure

Primary Safety Measurement [ Time Frame: 5-years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Los Angeles Institute of Foot and Ankle SurgeryMission HillsCalifornia91345
Armen Hagopjanian
[email protected]
Armen Hagopjanian, DPM (PRINCIPAL_INVESTIGATOR)
Florida Orthopedic Foot & Ankle CenterSarasotaFlorida34233
Liam Levings
[email protected]
941-924-8777
James Cottom, MD (PRINCIPAL_INVESTIGATOR)
Paley Orthopedic & Spine InstituteWest Palm BeachFlorida33407
Donna Cabral
[email protected]
561-844-5255
Bradley Lamm, DPM (PRINCIPAL_INVESTIGATOR)
Orthopaedic AssociatesEvansvilleIndiana47710
Teresa Shoultz, RN
[email protected]
812-424-9291
Charles A. Sisovsky, DPM (PRINCIPAL_INVESTIGATOR)
Department of Orthopedic Surgery, Johns Hopkins Outpatient CenterBaltimoreMaryland21287
Vaishali Laljani
[email protected]
410-502-2160
James Ficke, MD (PRINCIPAL_INVESTIGATOR)
New Mexico Bone and Joint InstituteAlamogordoNew Mexico88310
Jaye-Tee Higgins
[email protected]
864-940-5530
John J Anderson, DPM (PRINCIPAL_INVESTIGATOR)
Duke Orhtopaedics ArringdonMorrisvilleNorth Carolina27560
Kalyn Purnell
[email protected]
919-668-9175
James Nunley, MD (PRINCIPAL_INVESTIGATOR)
Mark Easley, MD (SUB_INVESTIGATOR)
Samuel Adams, MD (SUB_INVESTIGATOR)
Dept. of Orthopedic Surgery and Rehabilitation, University of OklahomaOklahoma CityOklahoma73104-
MUSC Department of Orthopaedics/Foot and Anke ServicesCharlestonSouth Carolina29425
Joshua Morningstar
[email protected]
423-778-3923
Seth Tysor
[email protected]
423-778-3923
Christopher Gross, MD (PRINCIPAL_INVESTIGATOR)
Spring Branch Podiatry, PLLCHoustonTexas77024
Candace Lopez
[email protected]
713-461-1010
Randal Beckman, DPM (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mission Hills, CA

By research site
Los Angeles Institute of Foot and Ankle Surgery· Mission Hills, CAFlorida Orthopedic Foot & Ankle Center· Sarasota, FLPaley Orthopedic & Spine Institute· West Palm Beach, FLOrthopaedic Associates· Evansville, INDepartment of Orthopedic Surgery, Johns Hopkins Outpatient Center· Baltimore, MDNew Mexico Bone and Joint Institute· Alamogordo, NM

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