OsteoarthritisActis14014NCT02783274
Actis Total Hip System 2 Year Follow-up
A study testing Actis Total Hip System in people with Osteoarthritis and Traumatic Arthritis, run by DePuy Orthopaedics at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Actis Total Hip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jul 2016to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- Subjects will be excluded if in the opinion of the Investigator, the individual meets any of the following exclusions:
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular
- 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).
- Charcot's or Paget's disease.
- 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.
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- The Subject is a woman who is pregnant or lactating.
- Existing contralateral hip that was implanted less than 6 months from the date of surgery at the time of consent into this study.
- 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.
- Subject had a contralateral amputation.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- 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.
- 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.
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Austin, Texas
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Lebanon, New Hampshire
Study site
Louisville, Kentucky, 40241
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Renton, Washington
Study site
Rochester, Minnesota
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head, Acute Traumatic Fracture of the Femoral Head or Neck
- Being tested
- Actis Total Hip System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Hip Dislocation, Congenital, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actis Total Hip SystemDevice
Also called Actis DuoFix Femoral Stem
Total Hip Replacement and Hemi-hip Replacement
| Study group | Role | What they receive |
|---|---|---|
| Actis Total Hip System | Other | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement Receives: Device: Actis Total Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Harris Hip Score- HHA 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.
Measured: 2 Years
Secondary outcomes (38)
Harris Hip Score- THA Subjects Per Protocol at 3 Months
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.
Measured: 3 months
Harris Hip Score- HHA Subjects Per Protocol at 3 Months
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.
Measured: 3 months
Harris Hip Score- THA Subjects Per Protocol at 1 Year
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.
Measured: 1 Year
Harris Hip Score- HHA Subjects Per Protocol at 1 Year
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 Years
Femoral Stem Position- HHA 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.
Measured: 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.
Measured: 2 Years
Number of Participants With Femoral Stem Tilt- HHA 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 Years
Femoral Stem Heterotopic Ossification- HHA 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.
Measured: 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.
Measured: 2 Years
Femoral Radiolucent Lines- HHA 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.
Measured: 2 Years
Femoral 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.
Measured: 2 Years
Femoral Osteolysis- HHA 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 2 Years
Femoral Stem Calcar Fracture- HHA 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.
Measured: 2 Years
Perceived Leg Length Discrepancy- THA Subjects Per Protocol
The number of subjects who perceived a Leg Length Discrepancy at Two Years
Measured: 2 Years
Perceived Leg Length Discrepancy- HHA Subjects Per Protocol
The number of subjects who perceived a Leg Length Discrepancy at Two Years
Measured: 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
Measured: 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
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start1 Jul 2016
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah German, BS, Study director, DePuy Synthes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783274
- Sponsor's protocol ID
- 14014
- Acronym
- Actis14014
- Status last verified
- Aug 2025
- First submitted
- 23 May 2016
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actis Total Hip System 2 Year Follow-up
- ClinicalTrials.gov ID
- NCT02783274
- Acronym / sponsor ID
- Actis14014 / 14014
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head, Acute Traumatic Fracture of the Femoral Head or Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 22 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Actis Total Hip System | Other | Device: Actis Total Hip SystemThe Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
Key exclusion criteria (15 listed)
- Subjects will be excluded if in the opinion of the Investigator, the individual meets any of the following exclusions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actis Total Hip SystemAlso: Actis DuoFix Femoral StemTotal Hip Replacement and Hemi-hip Replacement | Device | Actis Total Hip System |
Primary outcome
Harris Hip Score- THA Subjects Per Protocol at 2 Years
Time frame: 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.
Harris Hip Score- HHA Subjects Per Protocol at 2 Years
Time frame: 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.
38 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
Time frame: 2 Years
Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population
Time frame: 2 Years
Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol
Time frame: 2 Years
Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol
Time frame: 2 Years
Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects
Time frame: 2 Years
Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol
Time frame: 2 Years
Acetabular Radiolucent Lines- THA Subjects Per Protocol
Time frame: 2 Years
Acetabular Osteolysis- THA Subjects Per Protocol
Time frame: 2 Years
Acetabular Sclerotic Lines- THA Subjects Per Protocol
Time frame: 2 Years
Acetabular Porous Coating Integrity- THA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Position- THA Subjects Per Protocol
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
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
Time frame: 2 Years
Number of Participants With Femoral Stem Subsidence- HHA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
Time frame: 2 Years
Femoral Radiolucent Lines- THA Subjects Per Protocol
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
Time frame: 2 Years
Femoral Stem Sclerotic Lines- HHA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Porous Coating Integrity- THA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Porous Coating Integrity- HHA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Calcar Resorption- THA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Calcar Resorption- HHA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Calcar Fracture- THA Subjects Per Protocol
Time frame: 2 Years
Femoral Stem Calcar Fracture- HHA Subjects Per Protocol
Time frame: 2 Years
Perceived Leg Length Discrepancy- THA Subjects Per Protocol
Time frame: 2 Years
Perceived Leg Length Discrepancy- HHA Subjects Per Protocol
Time frame: 2 Years
Number of Participants With True Leg Length Discrepancy- THA Subjects Per Protocol
Time frame: 2 Years
Number of Participants With True Leg Length Discrepancy- HHA Subjects Per Protocol
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah German, BS study director
DePuy Synthes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actis Total Hip System in people with Osteoarthritis and Traumatic Arthritis, run by DePuy Orthopaedics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score- THA Subjects Per Protocol at 2 Years (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.