Back to resultsPost Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Primary Purpose
Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hintermann Series H3 Total Ankle Replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Ankle
Eligibility Criteria
Inclusion Criteria:
- Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator.
- Willingness to participate in the study and follow-up visits
- Written informed consent, including authorization to release collected health data
Exclusion Criteria:
- Skeletal immaturity
Bone stock inadequate to support the device including:
- Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
- Avascular necrosis of the talus
- Active or prior deep infection in the ankle joint or adjacent bones
Malalignment or severe deformity of involved or adjacent anatomic structures including:
- Hindfoot or forefoot malalignment precluding plantigrade foot
- Significant malalignment of the knee joint
- Insufficient ligament support that cannot be repaired with soft tissue stabilization (syndesmosis disruption)
- Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
- Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
- Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
- Poor skin and soft tissue quality about the surgical site
- Immunosupressive therapy
- Prior ankle fusion or revision of total ankle replacement
- High demanding sport activities (e.g., contact sports, jumping)
- Suspected or documented metal allergy or intolerance
- Condition or situation which, in the Physician's opinion, puts the subject at significant risk, or may interfere significantly with the subject's participation in the study
Sites / Locations
- Los Angeles Institute of Foot and Ankle SurgeryRecruiting
- Florida Orthopedic Foot & Ankle CenterRecruiting
- Paley Orthopedic & Spine InstituteRecruiting
- Orthopaedic AssociatesRecruiting
- Department of Orthopedic Surgery, Johns Hopkins Outpatient CenterRecruiting
- New Mexico Bone and Joint InstituteRecruiting
- Duke Orhtopaedics ArringdonRecruiting
- Dept. of Orthopedic Surgery and Rehabilitation, University of OklahomaRecruiting
- MUSC Department of Orthopaedics/Foot and Anke ServicesRecruiting
- Spring Branch Podiatry, PLLCRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment Arm
Arm Description
All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.
Outcomes
Primary Outcome Measures
Primary Safety Measurement
The Primary Safety Measurement for this study is the percentage of patient subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Primary Effectiveness Measurement
The co-primary effectiveness measurements for this study are the American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more, the survivorship (absence of removal/revisions of metal components) within 5 years post-surgery, and the percentage of subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04770870
Brief Title
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Official Title
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 2029 (Anticipated)
Study Completion Date
April 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DT MedTech, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).
The present version (third generation) of the H3 TAR and the earlier generations of this total ankle system have been marketed (initially in 2003) under a license agreement in Europe, South Korea, Australia, and Canada and other countries outside the U.S. (OUS). The H3 TAR prosthesis has been used in over 20,000 procedures in the markets OUS. The H3 TAR device has not been withdrawn from marketing for any reason.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, single arm post approval study of 232 subjects up to 10 US study sites
Masking
None (Open Label)
Allocation
N/A
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Other
Arm Description
All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.
Intervention Type
Device
Intervention Name(s)
Hintermann Series H3 Total Ankle Replacement System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Measurement
Description
The Primary Safety Measurement for this study is the percentage of patient subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Time Frame
5-years
Title
Primary Effectiveness Measurement
Description
The co-primary effectiveness measurements for this study are the American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more, the survivorship (absence of removal/revisions of metal components) within 5 years post-surgery, and the percentage of subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
Time Frame
5-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator.
Willingness to participate in the study and follow-up visits
Written informed consent, including authorization to release collected health data
Exclusion Criteria:
Skeletal immaturity
Bone stock inadequate to support the device including:
Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
Avascular necrosis of the talus
Active or prior deep infection in the ankle joint or adjacent bones
Malalignment or severe deformity of involved or adjacent anatomic structures including:
Hindfoot or forefoot malalignment precluding plantigrade foot
Significant malalignment of the knee joint
Insufficient ligament support that cannot be repaired with soft tissue stabilization (syndesmosis disruption)
Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
Poor skin and soft tissue quality about the surgical site
Immunosupressive therapy
Prior ankle fusion or revision of total ankle replacement
High demanding sport activities (e.g., contact sports, jumping)
Suspected or documented metal allergy or intolerance
Condition or situation which, in the Physician's opinion, puts the subject at significant risk, or may interfere significantly with the subject's participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Associate
Phone
3478223603
Email
amckibbin@msquaredassociates.com
First Name & Middle Initial & Last Name or Official Title & Degree
Study Project Manager
Phone
347.954.0542
Email
pweiman@msquaredassociates.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Tuznik
Organizational Affiliation
DT MedTech
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles Institute of Foot and Ankle Surgery
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melody Tuznik
Email
melody.tuznik@vilex.com
First Name & Middle Initial & Last Name & Degree
Armen Hagopjanian, DPM
Facility Name
Florida Orthopedic Foot & Ankle Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylie Hampton
Email
kylie.hampton@vilex.com
First Name & Middle Initial & Last Name & Degree
James Cottom, MD
Facility Name
Paley Orthopedic & Spine Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Cabral
Phone
561-844-5255
Ext
385
Email
dcabral@paleyinstitute.org
First Name & Middle Initial & Last Name & Degree
Bradley Lamm, DPM
Facility Name
Orthopaedic Associates
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Shoultz, RN
Phone
812-424-9291
Email
teresa.shoultz@oaevansville.com
First Name & Middle Initial & Last Name & Degree
Charles A. Sisovsky, DPM
Facility Name
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaishali Laljani
Email
vparikh2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
James Kicke, MD
Facility Name
New Mexico Bone and Joint Institute
City
Alamogordo
State/Province
New Mexico
ZIP/Postal Code
88310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaye-Tee Higgins
Phone
864-940-5530
Email
jhiggins@newmexortho.com
First Name & Middle Initial & Last Name & Degree
John J Anderson, DPM
Facility Name
Duke Orhtopaedics Arringdon
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalyn Purnell
Email
kalyn.purnell@duke.edu
First Name & Middle Initial & Last Name & Degree
James Nunley, MD
First Name & Middle Initial & Last Name & Degree
Mark Easley, MD
First Name & Middle Initial & Last Name & Degree
Samuel Adams, MD
Facility Name
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Edge
Email
kathy-edge@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Amgad Haleem, MD
Facility Name
MUSC Department of Orthopaedics/Foot and Anke Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Morningstar
Phone
704-249-0649
Email
morninjo@musc.edu
First Name & Middle Initial & Last Name & Degree
Christopher Gross, MD
Facility Name
Spring Branch Podiatry, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace Lopez
Phone
713-461-1010
Email
springbranchpodiatry@gmail.com
First Name & Middle Initial & Last Name & Degree
Randal Beckman, DPM
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
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