Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

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.

Eligibility

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

Conditions4

Locations10 sites

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