An interventional study of Actis Total Hip System in Osteoarthritis, Traumatic Arthritis and Rheumatoid Arthritis, sponsored by DePuy Orthopaedics. Completed at 9 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 266 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
First submitted after DePuy Orthopaedics became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Total primary hip replacement is indicated in the following conditions:
Certain cases of ankylosis.
Hemi-hip arthroplasty is indicated in the following conditions:
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:
Exclusion Criteria:
Subjects will be excluded if in the opinion of the Investigator, the individual meets any of the following exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
Device: Actis Total Hip System
Total Hip Replacement and Hemi-hip Replacement
Also known as: Actis DuoFix Femoral Stem
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
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- 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
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
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 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
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 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
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 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
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.
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
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
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
All eligible patients were asked if they were interested in study participation. 266 Hips in 266 Patients were enrolled into the study.
| Milestone | Actis Total Hip System |
|---|---|
| Started | 266 |
| Treated | 255 |
| Total hip replacement participants (tha) | 232 |
| Hemi-hip replacement participants (hha) | 23 |
| Completed | 191 |
| Not completed | 75 |
| Withdrew: Withdrawal by subject | 16 |
| Withdrew: Physician decision | 6 |
| Withdrew: Death | 9 |
| Withdrew: Lost to follow-up | 22 |
| Withdrew: Other | 22 |
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.
| units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- THA Subjects Per Protocol at 2 Years | 95.7 ± 9.3 |
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.
| units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- HHA Subjects Per Protocol at 2 Years | 83.2 ± 15.3 |
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.
| Units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- THA Subjects Per Protocol at 3 Months | 93.5 ± 8.7 |
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.
| units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- HHA Subjects Per Protocol at 3 Months | 85.3 ± 14.3 |
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.
| Units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- THA Subjects Per Protocol at 1 Year | 95.7 ± 9.0 |
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.
| units on a scale | Actis Total Hip System |
|---|---|
| Harris Hip Score- HHA Subjects Per Protocol at 1 Year | 85.8 ± 12.6 |
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.
| Percentage of hip Implants | Actis Total Hip System |
|---|---|
| Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population | 97.7 (94.5 to 99.0) |
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.
| Percentage of hip Implants | Actis Total Hip System |
|---|---|
| Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population | 99.6 (96.9 to 99.9) |
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.
| Degrees | Actis Total Hip System |
|---|---|
| Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol | 25.9 ± 3.89 |
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
| Degrees | Actis Total Hip System |
|---|---|
| Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol | 39.9 ± 4.87 |
Number of participants with greater than (\>) 4 degrees change in acetabular cup inclination angle at 2 years postoperatively was reported.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects | 1 (4.87 to —) |
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.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol | 0 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Acetabular Radiolucent Lines- THA Subjects Per Protocol | 5 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Acetabular Osteolysis- THA Subjects Per Protocol | 0 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Acetabular Sclerotic Lines- THA Subjects Per Protocol | 38 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Acetabular Porous Coating Integrity- THA Subjects Per Protocol | 0 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Neutral | 160 (4.87 to —) |
| Valgus | 3 (4.87 to —) |
| Varus | 5 (4.87 to —) |
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.
| Hips | Actis Total Hip System |
|---|---|
| Neutral | 5 (4.87 to —) |
| Valgus | 0 (4.87 to —) |
| Varus | 1 (4.87 to —) |
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.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With Femoral Stem Tilt - THA Subjects Per Protocol | 1 |
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.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With Femoral Stem Tilt- HHA Subjects Per Protocol | 0 |
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.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With Femoral Stem Subsidence- THA Subjects Per Protocol | 0 |
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.
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With Femoral Stem Subsidence- HHA Subjects Per Protocol | 0 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Class 0 | 98 |
| Class I | 55 |
| Class II | 11 |
| Class III | 3 |
| Unable to Assess | 1 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Class 0 | 2 |
| Class I | 2 |
| Class II | 0 |
| Class III | 2 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Radiolucent Lines- THA Subjects Per Protocol | 1 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Radiolucent Lines- HHA Subjects Per Protocol | 0 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Osteolysis- THA Subjects Per Protocol | 0 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Osteolysis- HHA Subjects Per Protocol | 0 |
Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Sclerotic Lines- THA Subjects Per Protocol | 102 |
Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Sclerotic Lines- HHA Subjects Per Protocol | 5 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Porous Coating Integrity- THA Subjects Per Protocol | 0 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Porous Coating Integrity- HHA Subjects Per Protocol | 0 |
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Calcar Resorption- THA Subjects Per Protocol | 73 |
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Calcar Resorption- HHA Subjects Per Protocol | 3 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Calcar Fracture- THA Subjects Per Protocol | 3 |
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.
| Hips | Actis Total Hip System |
|---|---|
| Femoral Stem Calcar Fracture- HHA Subjects Per Protocol | 0 |
The number of subjects who perceived a Leg Length Discrepancy at Two Years
| Participants | Actis Total Hip System |
|---|---|
| Perceived Leg Length Discrepancy- THA Subjects Per Protocol | 11 |
The number of subjects who perceived a Leg Length Discrepancy at Two Years
| Participants | Actis Total Hip System |
|---|---|
| Perceived Leg Length Discrepancy- HHA Subjects Per Protocol | 0 |
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
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With True Leg Length Discrepancy- THA Subjects Per Protocol | 0 |
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
| Participants | Actis Total Hip System |
|---|---|
| Number of Participants With True Leg Length Discrepancy- HHA Subjects Per Protocol | 0 |
Collected over Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Actis Total Hip System | 9/255 (3.5%) | 8/255 (3.1%) | 22/255 (8.6%) |
| Event | Actis Total Hip System |
|---|---|
| Post procedural infectionInfections and infestations | 2/255 |
| Wound AbscessInfections and infestations | 1/255 |
| Wound decompositionInjury, poisoning and procedural complications | 1/255 |
| Cardiac arrestCardiac disorders | 1/255 |
| Medical device site joint infectionInfections and infestations | 1/255 |
| Joint dislocationInjury, poisoning and procedural complications | 1/255 |
| Device dislocationProduct Issues | 1/255 |
| Device failureProduct Issues | 1/255 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/255 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/255 |
| Event | Actis Total Hip System |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/255 |
| Joint dislocationInjury, poisoning and procedural complications | 5/255 |
| FallInjury, poisoning and procedural complications | 3/255 |
| BursitisMusculoskeletal and connective tissue disorders | 2/255 |
| Impaired healingGeneral disorders | 2/255 |
| PyrexiaGeneral disorders | 2/255 |
All Implanted Participants (n=255)
| Age, Continuous(Years) | Actis Total Hip System |
|---|---|
| Mean | 62.6 ± 11.66 |
| Sex: Female, Male(Participants) | Actis Total Hip System |
|---|---|
| Female | 119 |
| Male | 136 |
| Ethnicity (NIH/OMB)(Participants) | Actis Total Hip System |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 247 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Actis Total Hip System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 20 |
| White | 231 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Implanted Participant Primary Diagnosis(Participants) | Actis Total Hip System |
|---|---|
| Acute Fracture | 22 |
| Avascular Necrosis | 8 |
| Degenerative Joint Disease | 41 |
| Hip Dysplasia | 2 |
| Osteoarthritis | 179 |
| Rheumatoid Arthritis | 1 |
| Other | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Data sharing details ↗ · yoda.yale.edu
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.