Phase
Condition
Rheumatoid Arthritis
Osteoarthritis
Arthritis And Arthritic Pain
Treatment
KINCISE(TM) Surgical Automated System
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient is undergoing a standard of care primary cementless hip replacement withthe Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. Alldevices are to be used according to the approved indications.
- Individuals who are able to speak, read, and comprehend the Institutional Review Boardapproved Informed Consent Document and willing and able to provide informed patientconsent for participation in the study and have authorized the transfer of his/herinformation to DePuy Synthes.
- Individuals who are willing and able to complete follow-up visits and questionnairesas specified by the study protocol.
- Individuals who are not bedridden per the discretion of the investigator (The intentof "not bedridden" means a permanent situation, not a temporary situation as in a hipfracture or trauma case).
- Individuals who are a minimum age of 21 years at the time of consent.
Exclusion
Exclusion Criteria:
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular deficiency in the affectedlimb rendering the procedure unjustified.
- Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there couldbe considerable migration of the prosthesis or a significant chance of fracture of thefemoral shaft and/or the lack of adequate bone to support the implant(s).
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
- Subject had a contralateral amputation.
- Previous partial hip replacement in affected hip.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Contralateral hip was replaced less than 3 months prior to surgery date, contralateralhip is already enrolled in the study, or simultaneous or staged hip replacement isplanned
- Subject is currently involved in any personal injury litigation, medical-legal orworker's compensation claims.
- Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgia orpolymyalgia.
- Subject has a medical condition with less than 2 years of life expectancy.
- Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has aphysical or psychological disorder that could affect their ability to complete patientreported questionnaires or be compliant with follow-up requirements.
Study Design
Study Description
Connect with a study center
The Orthopedic Specialty Center of Northern California
Roseville, California 95678
United StatesSite Not Available
Colorado Joint Replacement
Denver, Colorado 80210
United StatesSite Not Available
Capital Region Orthopaedic Group
Albany, New York 12208
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Carolina Orthopaedic & Sports Medicine
Gastonia, North Carolina 28054
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Southern Joint Replacement Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Institute for Hip and Knee Surgery
Austin, Texas 78751
United StatesSite Not Available
North Texas Medical Research Institute
Dallas, Texas 75254
United StatesSite Not Available
W.B. Carrell Memorial Clinic
Dallas, Texas 75231
United StatesSite Not Available
Jordan-Young Institute
Virginia Beach, Virginia 23462
United StatesSite Not Available

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