Trial Outcomes & Findings for Actis Total Hip System 2 Year Follow-up (NCT NCT02783274)
NCT ID: NCT02783274
Last Updated: 2025-08-15
Results Overview
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.
COMPLETED
NA
266 participants
2 Years
2025-08-15
Participant Flow
All eligible patients were asked if they were interested in study participation. 266 Hips in 266 Patients were enrolled into the study.
Unit of analysis: Hips
Participant milestones
| Measure |
Actis Total Hip System
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Overall Study
STARTED
|
266 266
|
|
Overall Study
Treated
|
255 255
|
|
Overall Study
Total Hip Replacement Participants (THA)
|
232 232
|
|
Overall Study
Hemi-hip Replacement Participants (HHA)
|
23 23
|
|
Overall Study
COMPLETED
|
191 191
|
|
Overall Study
NOT COMPLETED
|
75 75
|
Reasons for withdrawal
| Measure |
Actis Total Hip System
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Death
|
9
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Other
|
22
|
Baseline Characteristics
All implanted participants (n=255)
Baseline characteristics by cohort
| Measure |
Actis Total Hip System
n=255 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 11.66 • n=5 Participants • All implanted participants (n=255)
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants • Implanted Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants • Implanted Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants • Implanted Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
247 Participants
n=5 Participants • Implanted Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
White
|
231 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants • Implanted Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Acute Fracture
|
22 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Avascular Necrosis
|
8 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Degenerative Joint Disease
|
41 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Hip Dysplasia
|
2 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Osteoarthritis
|
179 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Rheumatoid Arthritis
|
1 Participants
n=5 Participants • Implanted Participants
|
|
Implanted Participant Primary Diagnosis
Other
|
2 Participants
n=5 Participants • Implanted Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: All implanted participants who attended their 2-year clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=166 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- THA Subjects Per Protocol at 2 Years
|
95.7 units on a scale
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: All implanted participants who attended their 2-year clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=5 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- HHA Subjects Per Protocol at 2 Years
|
83.2 units on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All implanted participants who attended their 3-month clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=189 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- THA Subjects Per Protocol at 3 Months
|
93.5 Units on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All implanted participants who attended their 3-month clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=9 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- HHA Subjects Per Protocol at 3 Months
|
85.3 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All implanted participants who attended their 1-year clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=186 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- THA Subjects Per Protocol at 1 Year
|
95.7 Units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All implanted participants who attended their 1-year clinical evaluation
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.
Outcome measures
| Measure |
Actis Total Hip System
n=5 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Harris Hip Score- HHA Subjects Per Protocol at 1 Year
|
85.8 units on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All THA implanted Participants
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.
Outcome measures
| Measure |
Actis Total Hip System
n=255 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Post-Operative 2-Year Device Survivorship- THA Subjects Safety Population
|
97.7 Percentage of hip Implants
Interval 94.5 to 99.0
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All THA Implanted Participants
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.
Outcome measures
| Measure |
Actis Total Hip System
n=255 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Post-Operative 2-Year Femoral Stem Survivorship- THA Subjects Safety Population
|
99.6 Percentage of hip Implants
Interval 96.9 to 99.9
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=166 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Shell Version at 2-years Postoperatively- THA Subjects Per Protocol
|
25.9 Degrees
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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
Outcome measures
| Measure |
Actis Total Hip System
n=16 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Shell Inclination at 2-years Postoperatively- THA Subjects Per Protocol
|
39.9 Degrees
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
Number of participants with greater than (\>) 4 degrees change in acetabular cup inclination angle at 2 years postoperatively was reported.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With >4 Degrees Change in Acetabular Cup Inclination Angle at 2 Years Postoperatively - THA Subjects
|
1 Participants
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With Acetabular Shell Migration >2mm at 2 Years Postoperatively - THA Subjects Per Protocol
|
0 Participants
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Radiolucent Lines- THA Subjects Per Protocol
|
5 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Osteolysis- THA Subjects Per Protocol
|
0 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Sclerotic Lines- THA Subjects Per Protocol
|
38 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Acetabular Porous Coating Integrity- THA Subjects Per Protocol
|
0 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Position- THA Subjects Per Protocol
Neutral
|
160 Hips
Interval 4.87 to
|
|
Femoral Stem Position- THA Subjects Per Protocol
Valgus
|
3 Hips
Interval 4.87 to
|
|
Femoral Stem Position- THA Subjects Per Protocol
Varus
|
5 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Position- HHA Subjects Per Protocol
Neutral
|
5 Hips
Interval 4.87 to
|
|
Femoral Stem Position- HHA Subjects Per Protocol
Valgus
|
0 Hips
Interval 4.87 to
|
|
Femoral Stem Position- HHA Subjects Per Protocol
Varus
|
1 Hips
Interval 4.87 to
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With Femoral Stem Tilt - THA Subjects Per Protocol
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With Femoral Stem Tilt- HHA Subjects Per Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With Femoral Stem Subsidence- THA Subjects Per Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With Femoral Stem Subsidence- HHA Subjects Per Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Class 0
|
98 Hips
|
|
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Class III
|
3 Hips
|
|
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Class I
|
55 Hips
|
|
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Class II
|
11 Hips
|
|
Femoral Stem Heterotopic Ossification- THA Subjects Per Protocol
Unable to Assess
|
1 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
Class 0
|
2 Hips
|
|
Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
Class I
|
2 Hips
|
|
Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
Class II
|
0 Hips
|
|
Femoral Stem Heterotopic Ossification- HHA Subjects Per Protocol
Class III
|
2 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Radiolucent Lines- THA Subjects Per Protocol
|
1 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Radiolucent Lines- HHA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Osteolysis- THA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Osteolysis- HHA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Sclerotic Lines- THA Subjects Per Protocol
|
102 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
Sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Sclerotic Lines- HHA Subjects Per Protocol
|
5 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Porous Coating Integrity- THA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Porous Coating Integrity- HHA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Calcar Resorption- THA Subjects Per Protocol
|
73 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Calcar Resorption- HHA Subjects Per Protocol
|
3 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=168 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Calcar Fracture- THA Subjects Per Protocol
|
3 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: All implanted participants with radiographs on file at the 2-year study visit
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.
Outcome measures
| Measure |
Actis Total Hip System
n=6 Hips
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Femoral Stem Calcar Fracture- HHA Subjects Per Protocol
|
0 Hips
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Implanted subjects who attended the 2-year clinic visit and answered this question.
The number of subjects who perceived a Leg Length Discrepancy at Two Years
Outcome measures
| Measure |
Actis Total Hip System
n=163 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Perceived Leg Length Discrepancy- THA Subjects Per Protocol
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Implanted subjects who attended the 2-year clinic visit and answered this question.
The number of subjects who perceived a Leg Length Discrepancy at Two Years
Outcome measures
| Measure |
Actis Total Hip System
n=2 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Perceived Leg Length Discrepancy- HHA Subjects Per Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Implanted subjects with a 2-year radiograph on file
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
Outcome measures
| Measure |
Actis Total Hip System
n=163 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With True Leg Length Discrepancy- THA Subjects Per Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Implanted subjects with a 2-year radiograph on file
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
Outcome measures
| Measure |
Actis Total Hip System
n=2 Participants
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Number of Participants With True Leg Length Discrepancy- HHA Subjects Per Protocol
|
0 Participants
|
Adverse Events
Actis Total Hip System
Serious adverse events
| Measure |
Actis Total Hip System
n=255 participants at risk
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Infections and infestations
Wound Abscess
|
0.39%
1/255 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Infections and infestations
Post procedural infection
|
0.78%
2/255 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Infections and infestations
Medical device site joint infection
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Product Issues
Device dislocation
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Product Issues
Device failure
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.39%
1/255 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
Other adverse events
| Measure |
Actis Total Hip System
n=255 participants at risk
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
8/255 • Number of events 12 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.0%
5/255 • Number of events 7 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
3/255 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.78%
2/255 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
General disorders
Impaired healing
|
0.78%
2/255 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
|
General disorders
Pyrexia
|
0.78%
2/255 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 2-year interval when the study closed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60