Actis Total Hip System 2 Year Follow-up
Two-year (2 year) information regarding the performance of the commercially available Actis™ Total Hip System in order to obtain and evaluate the clinical outcomes on a series of cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using clinical, radiographic and device and procedure related adverse event assessments.
‣ Total primary hip replacement is indicated in the following conditions:
• A severely painful and/or disable joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of ankylosis.
• Hemi-hip arthroplasty is indicated in the following conditions:
• Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
• Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
• Avascular necrosis of the femoral head.
• Non-union of femoral neck fractures.
• Certain high sub-capital and femoral neck fractures in the elderly.
⁃ Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
⁃ 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:
⁃ 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).
⁃ Individuals who are willing and able to return for follow-up as specified by the study protocol.
⁃ Individuals who are a minimum age of 21 years at the time of consent.
⁃ Individuals who are not bedridden.
⁃ 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.
⁃ 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.
⁃ 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.
⁃ 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.