Hintermann Series H3 Total Ankle Replacement System
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
This study is testing a new ankle replacement system to see if it helps people with painful arthritis in their ankles feel better and improve their mobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | DT MedTech, LLC Industry-sponsored |
| Locations | 10 sites (Mission Hills, California and 9 other locations) |
| Trial ID | NCT04770870 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Hintermann Series H3 Total Ankle Replacement (TAR) system, which is designed to replace painful arthritic ankle joints due to various forms of osteoarthritis. The H3 TAR prosthesis is a mobile bearing, non-cemented implant that has been used in over 20,000 procedures outside the U.S. The study aims to provide ongoing data to the FDA to ensure the safety and effectiveness of the device following its approval. Participants will be monitored for their outcomes and any adverse events related to the implant.
Who should consider this trial
Good fit: Ideal candidates include individuals suffering from primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory diseases.
Not a fit: Patients with skeletal immaturity, inadequate bone stock, active infections, or significant malalignment of the ankle or adjacent structures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a reliable option for alleviating pain and improving function in arthritic ankle joints.
How similar studies have performed: Previous studies of similar total ankle replacement systems have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mission Hills, California and 9 other locations
- Los Angeles Institute of Foot and Ankle Surgery — Mission Hills, California, United States (Recruiting)
- Florida Orthopedic Foot & Ankle Center — Sarasota, Florida, United States (Recruiting)
- Paley Orthopedic & Spine Institute — West Palm Beach, Florida, United States (Recruiting)
- Orthopaedic Associates — Evansville, Indiana, United States (Recruiting)
- Department of Orthopedic Surgery, Johns Hopkins Outpatient Center — Baltimore, Maryland, United States (Recruiting)
- New Mexico Bone and Joint Institute — Alamogordo, New Mexico, United States (Recruiting)
- Duke Orhtopaedics Arringdon — Morrisville, North Carolina, United States (Recruiting)
- Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma — Oklahoma City, Oklahoma, United States (Terminated)
- MUSC Department of Orthopaedics/Foot and Anke Services — Charleston, South Carolina, United States (Recruiting)
- Spring Branch Podiatry, PLLC — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: In House Clinical Research Associate
- Email: pwlasiuk@mcra.com
- Phone: 202.742.3869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.