| Eligibility |
Inclusion Criteria:
Total primary hip replacement is indicted in the following conditions:
1. A severely painful and/or disable joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Certain cases of ankylosis.
Hemi-hip arthroplasty is indicted in the following conditions:
5. Acute fracture of the femoral head or neck that cannot be appropriately reduced and
treated with internal fixation.
6. Fracture dislocation of the hip that cannot be appropriately reduced and treated with
internal fixation.
7. Avascular necrosis of the femoral head.
8. Non-union of femoral neck fractures.
9. Certain high sub-capital and femoral neck fractures in the elderly.
10. Degenerative arthritis involving only the femoral head in which the acetabulum does
not require replacement.
11. Pathology involving only the femoral head in which the acetabulum does not require
replacement.
Further inclusion criteria for individuals who, in the opinion of the Principal
Investigator, are suitable candidates for using the devices specified in this protocol
and they are as follows:
12. Individuals who are able to speak, read, and comprehend the informed patient consent
(IPC) 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 (Joint Reconstruction).
13. Individuals who are willing and able to return for follow-up as specified by the study
protocol.
14. Individuals who are a minimum age of 21 years at the time of consent.
15. Individuals who are not bedridden.
16. Individuals who are willing and able to complete the Subject Hip Outcomes
questionnaires (i.e., FJS-12, HOOS and Hip Evaluation) as specified by the study
protocol.
17. Individuals interested in participating in the parallel and optional Patient Activity
Tracking portion of the study are required to link the Patient Activity Tracking
device to their own well-functioning smartphone (i.e., iPhone or Android phone) via a
downloaded mobile application (i.e., ActiTrak™). If a Subject does not have a
smartphone, and would like to participate in the Patient Activity Tracking portion of
the study, the Sponsor will be able to provide an Android type tablet to which the
required app can be downloaded.
18. Individuals interested in participating in the optional Patient Activity Tracking
(ActiTrak™) portion of the study must be willing to wear the Patient Activity Tracking
device from the time of consent preoperative (if possible, based on date of consent)
and for 3 months postoperative.
19. Individuals interested in participating in the optional Patient Activity Tracking
(ActiTrak™) portion of the study must have the ability to return at the 3 month
follow-up visit in order to return the Patient Activity Tracking device, and if
applicable, the Sponsor's Android tablet back to the study site.
Exclusion Criteria:
- Subjects will be excluded if in the opinion of the Investigator, the individual meets
any of the following exclusions:
1. Active local or systemic infection.
2. Loss of musculature, neuromuscular compromise or vascular
3. Poor bone quality, such as osteoporosis, where in the surgeon's opinion, there
could be considerable migration of the prosthesis or a significant chance of
fracture of the femoral shaft and/or the lack of adequate bone to support the
implant(s).
4. Charcot's or Paget's disease.
5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as
distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis),
or migrating acetabuli, that would preclude the use of the natural acetabulum as
an appropriate articular surface for the hemi-hip prosthesis.
6. The Subject is a woman who is pregnant or lactating.
7. Existing contralateral hip that was implanted less than 6 months from the date of
surgery at the time of consent into this study.
8. Subjects requiring a simultaneous bilateral hip at the time of consent will be
excluded; there can be only one Actis™ study hip. This also means that even if
another hip system is used for the contralateral hip during simultaneous THAs,
the Subject will be excluded. As noted above, Subjects who have an existing
contralateral total hip replacement greater than 6 months postoperatively at the
time of consent may be entered into this study if they qualify based upon the
eligibility criteria and the approved labeling requirements.
9. Subject had a contralateral amputation.
10. Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three months.
11. Subject is currently involved in any personal injury litigation, medical-legal or
worker's compensation claims.
12. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a
psychological disorder that could affect their ability to complete patient
reported questionnaires or be compliant with follow-up requirements.
13. Subject was diagnosed and is 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 of life expectancy. Note:
Diabetes, at present, has not been established as a contraindication. However,
because of the increased risk for complications such as infection, slow wound
healing, etc., the physician should carefully consider the advisability of hip
replacement in the severely diabetic patient.
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