Tritanium® Primary Acetabular Shell Study
Sponsored by Stryker Orthopaedics
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 14 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- D. Patient is a candidate for a primary cementless total hip replacement.
- E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
- F. Patient has a Body Mass Index (BMI) ≥ 40.
- G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- L. Patient has a known sensitivity to device materials.
- M. Patient is a prisoner.