Actis Total Hip System 2 Year Follow-up

DePuy Orthopaedics266 enrolled

Overview

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.

A minimum of 10 study sites. A prospective, uncontrolled, non-randomized, multicenter study. A total of 255 Subjects to include a minimum of 225 Primary THA Subjects and a Sub-group with a minimum of 30 hemi-hip arthroplasty Subjects will be prospectively enrolled into the study. All Subjects will be seen for a preoperative clinic visit at the time of consent, and evaluated at the time of surgery, 6 weeks (28-70 days), 3 months (71-132 days), minimum 1 year (304-668 days), and minimum 2 years (669-1,763 days) postoperatively.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

266

Conditions

Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Total primary hip replacement is indicated 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 indicated 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.

Locations (9)

Unnamed facility

Louisville, Kentucky, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Rochester, Minnesota, United States

Unnamed facility

Lebanon, New Hampshire, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Charlotte, North Carolina, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Unnamed facility

Austin, Texas, United States

Unnamed facility

Renton, Washington, United States

Outcomes

Primary Outcomes

Harris Hip Score- THA Subjects Per Protocol at 2 Years

The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent.

Time frame: 2 Years

Harris Hip Score- HHA Subjects Per Protocol at 2 Years

Time frame: 2 Years

Secondary Outcomes

Harris Hip Score- THA Subjects Per Protocol at 3 Months

Time frame: 3 months

Harris Hip Score- HHA Subjects Per Protocol at 3 Months

Time frame: 3 months

Harris Hip Score- THA Subjects Per Protocol at 1 Year

Time frame: 1 Year

Harris Hip Score- HHA Subjects Per Protocol at 1 Year

Time frame: 1 Year

Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population

Device survivorship at 2 years post-operatively is a secondary endpoint in this study. A revision is defined as a revision for any reason and device survival is defined as the lack of revision. A 2-year Kaplan-Meier survivorship estimate of the Actis Hip System in implanted hips is provided.

Time frame: 2 Years

Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population

A stem revision is defined as any stem revision for any reason and device survival is defined as the lack of revision. A 2-year Kaplan-Meier survivorship estimate of the Actis Hip System in implanted hips is provided.

Time frame: 2 Years

Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol

Acetabular cup version is the angle formed between the axis of the implant and the coronal plane of the body. Acetabular version typically ranges between 11.5 and 28.5 degrees.

Time frame: 2 Years

Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol

Acetabular cup inclination is the angle between the longitudinal axis of the patient and a perpendicular line to the major axis of the cup projection. The target acetabular cup inclination is between 30-50 degrees

Time frame: 2 Years

Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects

Number of participants with greater than (\>) 4 degrees change in acetabular cup inclination angle at 2 years postoperatively was reported.

Time frame: 2 Years

Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol

Number of participants with acetabular shell migration \>2mm at 2 years postoperatively were reported. Acetabular migration is the superior migration of the implant within the pelvic bone.

Time frame: 2 Years

Acetabular Radiolucent Lines- THA Subjects Per Protocol

Radiolucent lines are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack on bone ingrowth or possible loosening of the implant. Radiolucent lines greater than 1mm wide were considered reportable for this study.

Time frame: 2 Years

Acetabular Osteolysis- THA Subjects Per Protocol

Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.

Time frame: 2 Years

Acetabular Sclerotic Lines- THA Subjects Per Protocol

Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.

Time frame: 2 Years

Acetabular Porous Coating Integrity- THA Subjects Per Protocol

Acetabular Cup Porous Coating Integrity is defined as the presence of one or more beads of the porous coating observed away from the component in the soft tissue adjacent to the device.

Time frame: 2 Years

Femoral Stem Position- THA Subjects Per Protocol

Femoral stem position is categorized as neutral, valgus, or varus. A neutral stem is centered within the femoral canal that runs through the center of the femur's long axis. A valgus femoral stem is positioned slightly towards the medial side of the femoral canal, and a varus femoral stem is positioned slightly towards the lateral side of the femoral canal.

Time frame: 2 Years

Femoral Stem Position- HHA Subjects Per Protocol

Time frame: 2 Years

Number of Participants With Femoral Stem Tilt - THA Subjects Per Protocol

Number of participants with femoral stem tilt were reported. Femoral stem tilt is a measurement taken at each post-operative year and compared against baseline images collected at 6-weeks post-operative. The measurement captures changes in the position of the femoral stem over time.

Time frame: 2 Years

Number of Participants With Femoral Stem Tilt- HHA Subjects Per Protocol

Time frame: 2 Years

Number of Participants With Femoral Stem Subsidence- THA Subjects Per Protocol

Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study.

Time frame: 2 Years

Number of Participants With Femoral Stem Subsidence- HHA Subjects Per Protocol

Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study.

Time frame: 2 Years

Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol

Heterotopic ossification is the abnormal formation of bone in soft tissues, such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is grade as Class 0 through Class IV, with Class 0 being least impactful and Class IV being most impactful.

Time frame: 2 Years

Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol

Time frame: 2 Years

Femoral Radiolucent Lines- THA Subjects Per Protocol

Radiolucencies are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack of bone ingrowth into the implant or possible loosening of the implant.

Time frame: 2 Years

Femoral Radiolucent Lines- HHA Subjects Per Protocol

Time frame: 2 Years

Femoral Osteolysis- THA Subjects Per Protocol

Time frame: 2 Years

Femoral Osteolysis- HHA Subjects Per Protocol

Time frame: 2 Years

Femoral Stem Sclerotic Lines- THA Subjects Per Protocol

Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.

Time frame: 2 Years

Femoral Stem Sclerotic Lines- HHA Subjects Per Protocol

Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.

Time frame: 2 Years

Femoral Stem Porous Coating Integrity- THA Subjects Per Protocol

Acetabular Cup Porous Coating Integrity is defined as the presence of one or more beads of the porous coating observed away from the component in the soft tissue adjacent to the device.

Time frame: 2 Years

Femoral Stem Porous Coating Integrity- HHA Subjects Per Protocol

Femoral Stem Porous Coating Integrity is defined as the presence of one or more beads of the porous coating observed away from the component in the soft tissue adjacent to the device.

Time frame: 2 Years

Femoral Stem Calcar Resorption- THA Subjects Per Protocol

Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb

Time frame: 2 Years

Femoral Stem Calcar Resorption- HHA Subjects Per Protocol

Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb

Time frame: 2 Years

Femoral Stem Calcar Fracture- THA Subjects Per Protocol

Near the top of the femur is a region of bone called the calcar femorale that provides strength to the femur when compressive forces are applied. During preparation of the femur to receive the femoral implant there is the possibility of fractures occurring in this region.

Time frame: 2 Years

Femoral Stem Calcar Fracture- HHA Subjects Per Protocol

Time frame: 2 Years

Perceived Leg Length Discrepancy- THA Subjects Per Protocol

The number of subjects who perceived a Leg Length Discrepancy at Two Years

Time frame: 2 Years

Perceived Leg Length Discrepancy- HHA Subjects Per Protocol

The number of subjects who perceived a Leg Length Discrepancy at Two Years

Time frame: 2 Years

Number of Participants With True Leg Length Discrepancy- THA Subjects Per Protocol

True LLD is defined as a difference of 3 cm or greater as reviewed via postoperative radiographs. The measurement is the distance between the superior-most aspects of the left and right femoral heads

Time frame: 2 Years

Number of Participants With True Leg Length Discrepancy- HHA Subjects Per Protocol

True LLD is defined as a difference of 3 cm or greater as reviewed via postoperative radiographs. The measurement is the distance between the superior-most aspects of the left and right femoral heads

Time frame: 2 Years

Actis Total Hip System 2 Year Follow-up

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes