Clinical trial NCT02783274: Actis Total Hip System 2 Year Follow-up
Official title: Actis Total Hip System 2 Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Traumatic Arthritis
Rheumatoid Arthritis
Congenital Hip Dysplasia
Avascular Necrosis of the Femoral Head
Acute Traumatic Fracture of the Femoral Head or Neck
Certain Cases of Ankylosis
Non-union of Femoral Neck Fractures
Certain High Sub-Capital & Femoral Neck Fractures in Elderly
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 266
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort of Total Hips and the protocol also includes a single cohort for Hemi-hips. No comparisons are made to comparator devices, no randomization (open label). gathering data for a Post-market clinical follow-up study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Harris Hip Score- THA Subjects Per Protocol at 2 Years
timeFrame: 2 Years
measure: Harris Hip Score- HHA Subjects Per Protocol at 2 Years
timeFrame: 2 Years
Secondary outcomes:
measure: Harris Hip Score- THA Subjects Per Protocol at 3 Months
timeFrame: 3 months
measure: Harris Hip Score- HHA Subjects Per Protocol at 3 Months
timeFrame: 3 months
measure: Harris Hip Score- THA Subjects Per Protocol at 1 Year
timeFrame: 1 Year
measure: Harris Hip Score- HHA Subjects Per Protocol at 1 Year
timeFrame: 1 Year
measure: Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population
timeFrame: 2 Years
measure: Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population
timeFrame: 2 Years
measure: Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects
timeFrame: 2 Years
measure: Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol
timeFrame: 2 Years
measure: Acetabular Radiolucent Lines- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Acetabular Osteolysis- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Acetabular Sclerotic Lines- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Acetabular Porous Coating Integrity- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Position- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Position- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With Femoral Stem Tilt - THA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With Femoral Stem Tilt- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With Femoral Stem Subsidence- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With Femoral Stem Subsidence- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Radiolucent Lines- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Radiolucent Lines- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Osteolysis- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Osteolysis- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Sclerotic Lines- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Sclerotic Lines- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Porous Coating Integrity- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Porous Coating Integrity- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Calcar Resorption- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Calcar Resorption- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Calcar Fracture- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Femoral Stem Calcar Fracture- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Perceived Leg Length Discrepancy- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Perceived Leg Length Discrepancy- HHA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With True Leg Length Discrepancy- THA Subjects Per Protocol
timeFrame: 2 Years
measure: Number of Participants With True Leg Length Discrepancy- HHA Subjects Per Protocol
timeFrame: 2 Years
Other outcomes:
Locations:
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Lebanon
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Renton
country: United States
state: Washington
Study officials:
affiliation: DePuy Synthes
name: Deborah German, BS
role: STUDY_DIRECTOR
References: