Phase
Condition
Osteoarthritis
Treatment
Polymotion Hip Resurfacing (PHR) System
Clinical Study ID
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
Requires primary hip resurfacing arthroplasty due to:
non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or
mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.
Harris Hip Score < 70 points.
Skeletally mature, age ≥21 and <65 years.
Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
Subjects who meet any of the following criteria will be excluded from participating in this study:
Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of >0.45.0F
Severe osteopenia, a medical history or increased risk of severe osteoporosis or severe osteopenia, a history of fragility fracture, and other conditions that lead to increased bone resorption
Osteonecrosis or avascular necrosis (AVN)
Multiple cysts of the femoral head (> 1cm) or cysts crossing the head-neck junction
Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)
Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head
Inflammatory arthritis such as rheumatoid arthritis (RA)
Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
Severe medical comorbidities, including:
severe cardiopulmonary disease,
congestive heart failure,
severe liver or kidney dysfunction,
end-stage renal disease,
severe uncontrolled diabetes,
history of IV drug use,
history of hypercoagulable state or pulmonary embolism,
severe lumbar spinal stenosis,
vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,
neuropathic arthropathy (Charcot joint),
immunosuppression or other immunodeficiency disorders, e.g., diseases such as Acquired Immune Deficiency Syndrome (AIDS) or post-organ transplant and on high doses of corticosteroids.
Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
BMI > 40
Active or suspected infection in or around the hip joint
Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
Pregnant or plan to become pregnant during the study duration
Current smoker
Study Design
Study Description
Connect with a study center
Orthopaedic and Physiotherapy Associates
Paget, Trevelyan DV04
BermudaActive - Recruiting
Florida Medical Clinic Orlando Health
Tampa, Florida 33613
United StatesActive - Recruiting
American Hip Institute & Orthopedic Specialists
Chicago, Illinois 60602
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Sinai Hospital / LifeBridge Health
Baltimore, Maryland 21215
United StatesActive - Recruiting
NYU Longone
New York, New York 10003
United StatesActive - Recruiting
Joint Implant Surgeons
New Albany, Ohio 43054
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Rothman Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina 29210
United StatesActive - Recruiting
Hampton Road Orthopaedics
Newport News, Virginia 23606
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.