Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Launched by DT MEDTECH, LLC · Feb 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the H3 Total Ankle Replacement System, which is designed for people suffering from ankle arthritis, including osteoarthritis and post-traumatic arthritis. The purpose of the study is to gather more information on the safety and effectiveness of this device after its approval by the FDA. The trial is currently recruiting participants who are between 70 to 76 years old and are suitable candidates for this type of ankle surgery, as determined by the study doctor. Eligible individuals must be willing to participate and agree to follow-up visits, and they will need to provide written consent to share their health information.

Participants in this study can expect to undergo the ankle replacement procedure and will be monitored over time to assess their recovery and the device's performance. However, there are some criteria that may prevent someone from joining, such as having poor bone quality, previous infections in the ankle, or certain health conditions that could complicate surgery. This study is important because it helps ensure that the ankle replacement system remains safe and effective for patients in the long term.

Gender

ALL

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