Phase
Condition
Joint Injuries
Osteoarthritis
Treatment
Hintermann Series H3 Total Ankle Replacement System
Clinical Study ID
Ages > 21 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Each potential subject must be an appropriate candidate for mobile bearing TAR byhaving: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritissecondary 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
Exclusion Criteria:
Skeletal immaturity
Bone stock inadequate to support the device including:
Severe osteoporotic or osteopenic condition or other conditions resulting inpoor 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 structuresincluding:
Hindfoot or forefoot malalignment precluding plantigrade foot
Significant malalignment of the knee joint
Insufficient ligament support that cannot be repaired with soft tissuestabilization (syndesmosis disruption)
Charcot joint or peripheral neuropathy that may lead to Charcot joint of theaffected ankle
Neuromuscular disease resulting in lack of normal muscle function about the affectedankle
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 atsignificant risk, or may interfere significantly with the subject's participation inthe study
Study Design
Study Description
Connect with a study center
Phoenix Foot and Ankle Institute
Scottsdale, Arizona 85251
United StatesSite Not Available
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California 91345
United StatesActive - Recruiting
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida 34233
United StatesActive - Recruiting
Paley Orthopedic & Spine Institute
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Orthopaedic Associates
Evansville, Indiana 47710
United StatesActive - Recruiting
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland 21287
United StatesActive - Recruiting
New Mexico Bone and Joint Institute
Alamogordo, New Mexico 88310
United StatesActive - Recruiting
Duke Orhtopaedics Arringdon
Morrisville, North Carolina 27560
United StatesActive - Recruiting
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesTerminated
MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina 29425
United StatesActive - Recruiting
Spring Branch Podiatry, PLLC
Houston, Texas 77024
United StatesActive - Recruiting
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