| Primary | 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. | All implanted participants who attended their 2-year clinical evaluation | Posted | | Mean | Standard Deviation | units on a scale | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | | Title | Denominators | Categories |
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| Primary | 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. | All implanted participants who attended their 2-year clinical evaluation | Posted | | Mean | Standard Deviation | units on a scale | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants who attended their 3-month clinical evaluation | Posted | | Mean | Standard Deviation | Units on a scale | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants who attended their 3-month clinical evaluation | Posted | | Mean | Standard Deviation | units on a scale | | 3 months | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants who attended their 1-year clinical evaluation | Posted | | Mean | Standard Deviation | Units on a scale | | 1 Year | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants who attended their 1-year clinical evaluation | Posted | | Mean | Standard Deviation | units on a scale | | 1 Year | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All THA implanted Participants | Posted | | Number | 95% Confidence Interval | Percentage of hip Implants | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All THA Implanted Participants | Posted | | Number | 95% Confidence Interval | Percentage of hip Implants | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Mean | Standard Deviation | Degrees | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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 | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Mean | Standard Deviation | Degrees | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | Units | Counts |
|---|
| Participants | | | Hips |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
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| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | Units | Counts |
|---|
| Participants | | | Hips |
|
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | Units | Counts |
|---|
| Participants | | | Hips |
|
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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 | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | Units | Counts |
|---|
| Participants | | | Hips |
|
| Secondary | 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 | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | Units | Counts |
|---|
| Participants | | | Hips |
|
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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. | All implanted participants with radiographs on file at the 2-year study visit | Posted | | Count of Units | | Hips | | 2 Years | Hips | Hips | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | Perceived Leg Length Discrepancy- THA Subjects Per Protocol | The number of subjects who perceived a Leg Length Discrepancy at Two Years | Implanted subjects who attended the 2-year clinic visit and answered this question. | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | |
| Secondary | Perceived Leg Length Discrepancy- HHA Subjects Per Protocol | The number of subjects who perceived a Leg Length Discrepancy at Two Years | Implanted subjects who attended the 2-year clinic visit and answered this question. | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| | |
| Secondary | 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 | Implanted subjects with a 2-year radiograph on file | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |
| Secondary | 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 | Implanted subjects with a 2-year radiograph on file | Posted | | Count of Participants | | Participants | | 2 Years | | | | ID | Title | Description |
|---|
| OG000 | Actis Total Hip System | The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement |
| |