Eligibility Details:
Inclusion Criteria:
1. Individuals requiring primary THA for a severely painful and/or disabled joint from
osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip
dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or
neck
2. Individuals who are able to speak, read and comprehend the informed patient consent
document and willing and able to provide informed patient consent for participation in
the study and have authorized the transfer of his/her information to DePuy Synthes
3. Individuals who are willing and able to return for follow-up as specified by the study
protocol
4. Individuals who are a minimum age of 21 years at the time of consent
5. Individuals who are willing and able to complete the Subject Hip Outcomes
questionnaires as specified by the study protocol
Exclusion Criteria:
1. Individuals have active local or systemic infection
2. Individuals who have loss of musculature, neuromuscular compromise or vascular
compromise that would impact rehabilitation following surgery
3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's
opinion, there could be considerable migration of the prosthesis or require additional
acetabular cup fixation using screws, or a significant chance of fracture of the
femoral shaft and/or the lack of adequate bone to support the implant(s)
4. Individuals with Charcot's or Paget's disease
5. Individuals who, in the judgement of the investigator, would not be a candidate for
protocol allowable components to be used for their THA
6. Women that are pregnant or lactating
7. Individuals who have had a contralateral hip that was implanted less than 6 months
prior to the time of consent into this study or individuals that expect to have a
contralateral hip implanted in the following 6 months at the time of consent into this
study
8. Individuals that have amputations in either leg that would impact rehabilitation
following surgery
9. Individuals who are bedridden.
10. Individuals that have participated in a clinical investigation with an investigational
product (drug or device) in the last three months
11. Individuals currently involved in any personal injury litigation, medical-legal or
worker's compensation claims
12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or
have psychological disorders that could affect their ability to complete patient
reported questionnaires or be compliant with follow-up requirements
13. Individuals diagnosed and taking prescription medications to treat a muscular disorder
that limits mobility due to severe stiffness and pain such as fibromyalgia or
polymyalgia
14. Subject has a medical condition with less than 2 years life expectancy
15. Individual has a BMI >45 kg/m2.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
