Clinical trial NCT04770870: 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
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Ankle
Post-Traumatic Osteoarthritis of Ankle
Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
Lead sponsor: DT MedTech, LLC
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 232
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, single arm post approval study of 232 subjects up to 10 US study sites
Primary purpose: TREATMENT

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 The H3 TAR device has not been withdrawn from marketing for any reason.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.

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

Primary outcomes:
measure: Primary Safety Measurement
timeFrame: 5-years
measure: Primary Effectiveness Measurement
timeFrame: 5-years
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Hills
country: United States
facility: Los Angeles Institute of Foot and Ankle Surgery
state: California
city: Sarasota
country: United States
facility: Florida Orthopedic Foot & Ankle Center
state: Florida
city: West Palm Beach
country: United States
facility: Paley Orthopedic & Spine Institute
state: Florida
city: Evansville
country: United States
facility: Orthopaedic Associates
state: Indiana
city: Baltimore
country: United States
facility: Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
state: Maryland
city: Alamogordo
country: United States
facility: New Mexico Bone and Joint Institute
state: New Mexico
city: Morrisville
country: United States
facility: Duke Orhtopaedics Arringdon
state: North Carolina
city: Oklahoma City
country: United States
facility: Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: MUSC Department of Orthopaedics/Foot and Anke Services
state: South Carolina
city: Houston
country: United States
facility: Spring Branch Podiatry, PLLC
state: Texas
Study officials:
References: