Degenerative Arthritis, Osteoarthritis
Conditions
Brief summary
The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.
Interventions
DEVICETHA
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck 2. Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes 3. Individuals who are willing and able to return for follow-up as specified by the study protocol 4. Individuals who are a minimum age of 21 years at the time of consent 5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol
Exclusion criteria
1. Individuals have active local or systemic infection 2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery 3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s) 4. Individuals with Charcot's or Paget's disease 5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA 6. Women that are pregnant or lactating 7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months at the time of consent into this study 8. Individuals that have amputations in either leg that would impact rehabilitation following surgery 9. Individuals who are bedridden. 10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months 11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims 12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements 13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia 14. Subject has a medical condition with less than 2 years life expectancy 15. Individual has a BMI \>45 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | At 6 week and 2 years | RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined |
| Patient Reported Outcome Measures (PROMs)- HOOS Jr. | Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years | Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome). |
| Patient Reported Outcome Measures (PROMs)- FJS-12 | At 6 weeks, 3 months, 6 months, 1 year and 2 years | The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of forgetting the artificial joint, that is, a low degree of awareness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other RSA Measurements (Rotations) | At 6 weeks, 3 months, 6 months, 1 year, 2 years | X, Y, and Z rotations in degrees at all time points |
| RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | At 3 months, 6 months and 1 year | — |
| Patient Reported Outcome Measures (PROMs)- Harris Hip Score | Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years | The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result. |
| Linear Head Penetration | At 1 year and 2 years | Linear head penetration at 1 year and 2 years for each surgical approach separately was reported. |
| Other RSA Measurements (X-Translations) | At 6 weeks, 3 months, 6 months, 1 year, 2 years | Other RSA measurements (X translations in mm) at all time points |
| Other RSA Measurements (Z-Translations) | At 6 weeks, 3 months, 6 months, 1 year, 2 years | Other RSA measurements (Z translations in mm) at all time points |
Countries
Canada
Participant flow
Pre-assignment details
Out of total 100 participants enrolled, 84 participants underwent surgery via either posterior, lateral, or anterior approach. The remaining 16 participants were either withdrawn prior to surgery or the study was terminated prior to surgery and thus they were not included in a surgical approach group.
Participants by arm
| Arm | Count |
|---|---|
| Posterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach | 40 |
| Lateral Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach | 20 |
| Anterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach | 24 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Inclusion/Exclusion Criteria not met | 2 | 0 | 1 |
| Overall Study | Other | 1 | 1 | 0 |
| Overall Study | Study Terminated by Sponsor | 7 | 8 | 23 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Posterior Approach | Lateral Approach | Anterior Approach | Total |
|---|---|---|---|---|
| Age, Continuous | 69.53 years STANDARD_DEVIATION 8.85 | 65.0 years STANDARD_DEVIATION 9.39 | 60.5 years STANDARD_DEVIATION 12.72 | 65.87 years STANDARD_DEVIATION 10.81 |
| BMI | 31.19 kg/m2 STANDARD_DEVIATION 6.73 | 30.36 kg/m2 STANDARD_DEVIATION 6.75 | 30.32 kg/m2 STANDARD_DEVIATION 5.43 | 30.74 kg/m2 STANDARD_DEVIATION 6.33 |
| Primary Diagnosis Avascular necrosis | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Primary Diagnosis Degenerative Joint Disease | 34 Participants | 14 Participants | 0 Participants | 48 Participants |
| Primary Diagnosis Osteoarthritis | 5 Participants | 6 Participants | 23 Participants | 34 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 11 Participants | 9 Participants | 40 Participants |
| Sex: Female, Male Male | 20 Participants | 9 Participants | 15 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 0 / 20 | 0 / 24 |
| other Total, other adverse events | 9 / 40 | 4 / 20 | 7 / 24 |
| serious Total, serious adverse events | 8 / 40 | 2 / 20 | 5 / 24 |
Outcome results
Primary
Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined
Time frame: At 6 week and 2 years
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 6 weeks | -0.001 mm | Standard Deviation 0.065 |
| Posterior Approach | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 2yrs | 0.06 mm | Standard Deviation 0.292 |
| Lateral Approach | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 2yrs | 0.045 mm | Standard Deviation 0.501 |
| Lateral Approach | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 6 weeks | -0.03 mm | Standard Deviation 0.094 |
| Anterior Approach | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 6 weeks | -0.036 mm | Standard Deviation 0.133 |
| Overall Population | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 6 weeks | -0.02 mm | Standard Deviation 0.099 |
| Overall Population | Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years | RSA Measured Subsidence (Y-axis Translation) at 2yrs | 0.055 mm | Standard Deviation 0.362 |
Primary
Patient Reported Outcome Measures (PROMs)- FJS-12
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of forgetting the artificial joint, that is, a low degree of awareness.
Time frame: At 6 weeks, 3 months, 6 months, 1 year and 2 years
Population: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 1 year follow-up | 82.06 Units on a scale | Standard Deviation 22.58 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 3 months follow-up | 63.35 Units on a scale | Standard Deviation 26.5 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 2 years follow-up | 82.67 Units on a scale | Standard Deviation 23.72 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 months follow-up | 67.33 Units on a scale | Standard Deviation 29.78 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 weeks follow-up | 54.74 Units on a scale | Standard Deviation 26.14 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 2 years follow-up | 84.72 Units on a scale | Standard Deviation 11.02 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 1 year follow-up | 75.87 Units on a scale | Standard Deviation 27.91 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 weeks follow-up | 48.14 Units on a scale | Standard Deviation 29.7 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 3 months follow-up | 70.27 Units on a scale | Standard Deviation 31.71 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 months follow-up | 81.88 Units on a scale | Standard Deviation 18.94 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 months follow-up | 82.64 Units on a scale | Standard Deviation 20.06 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 1 year follow-up | 91.95 Units on a scale | Standard Deviation 10.79 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 6 weeks follow-up | 55.88 Units on a scale | Standard Deviation 28.93 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- FJS-12 | FJS-12 Score at 3 months follow-up | 69.26 Units on a scale | Standard Deviation 29.48 |
Primary
Patient Reported Outcome Measures (PROMs)- HOOS Jr.
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome).
Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Population: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 1 year follow-up | 92.71 Units on a scale | Standard Deviation 11.22 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 3 months follow-up | 83.17 Units on a scale | Standard Deviation 14.02 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 2 years follow-up | 89.76 Units on a scale | Standard Deviation 15.98 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 months follow-up | 85.7 Units on a scale | Standard Deviation 14.98 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 weeks follow-up | 78.99 Units on a scale | Standard Deviation 11.68 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at Pre-op | 52.61 Units on a scale | Standard Deviation 11.92 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 2 years follow-up | 94.5 Units on a scale | Standard Deviation 7.42 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at Pre-op | 54.47 Units on a scale | Standard Deviation 13.99 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 weeks follow-up | 80.22 Units on a scale | Standard Deviation 14.96 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 3 months follow-up | 88.37 Units on a scale | Standard Deviation 13.91 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 1 year follow-up | 91.7 Units on a scale | Standard Deviation 15.27 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 months follow-up | 90.64 Units on a scale | Standard Deviation 14.19 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 weeks follow-up | 75.78 Units on a scale | Standard Deviation 12.22 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at Pre-op | 52.88 Units on a scale | Standard Deviation 16.63 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 1 year follow-up | 97.54 Units on a scale | Standard Deviation 6.02 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 3 months follow-up | 89.07 Units on a scale | Standard Deviation 12.62 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- HOOS Jr. | HOOS Jr. at 6 months follow-up | 89.89 Units on a scale | Standard Deviation 12 |
Secondary
Linear Head Penetration
Linear head penetration at 1 year and 2 years for each surgical approach separately was reported.
Time frame: At 1 year and 2 years
Population: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Linear Head Penetration | Linear Head Penetration at 1 year f/up | 0.182 mm | Standard Deviation 0.107 |
| Posterior Approach | Linear Head Penetration | Linear Head Penetration at 2 years f/up | 0.228 mm | Standard Deviation 0.101 |
| Lateral Approach | Linear Head Penetration | Linear Head Penetration at 1 year f/up | 0.211 mm | Standard Deviation 0.09 |
| Lateral Approach | Linear Head Penetration | Linear Head Penetration at 2 years f/up | 0.321 mm | Standard Deviation 0.192 |
| Anterior Approach | Linear Head Penetration | Linear Head Penetration at 1 year f/up | 0.286 mm | Standard Deviation 0.086 |
Secondary
Other RSA Measurements (Rotations)
X, Y, and Z rotations in degrees at all time points
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 3 months | 0.027 Degrees | Standard Deviation 0.966 |
| Posterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 3 months | -0.368 Degrees | Standard Deviation 1.046 |
| Posterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 months | -0.241 Degrees | Standard Deviation 0.81 |
| Posterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 3 months | -0.196 Degrees | Standard Deviation 0.475 |
| Posterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 1 year | 0.043 Degrees | Standard Deviation 0.494 |
| Posterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 1 year | 0.067 Degrees | Standard Deviation 0.523 |
| Posterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 Weeks | 0.023 Degrees | Standard Deviation 0.368 |
| Posterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 2 years | -0.223 Degrees | Standard Deviation 0.703 |
| Posterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 1 year | -0.024 Degrees | Standard Deviation 0.575 |
| Posterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 2 years | 0.216 Degrees | Standard Deviation 0.801 |
| Posterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 2 years | 0.284 Degrees | Standard Deviation 0.714 |
| Posterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 months | 0.062 Degrees | Standard Deviation 0.591 |
| Posterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 weeks | 0.035 Degrees | Standard Deviation 0.472 |
| Posterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 weeks | 0.045 Degrees | Standard Deviation 0.35 |
| Posterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 months | 0.137 Degrees | Standard Deviation 0.967 |
| Lateral Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 2 years | -0.001 Degrees | Standard Deviation 0.793 |
| Lateral Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 2 years | 0.26 Degrees | Standard Deviation 1.392 |
| Lateral Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 3 months | -0.021 Degrees | Standard Deviation 1.311 |
| Lateral Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 3 months | 0.053 Degrees | Standard Deviation 1.715 |
| Lateral Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 months | -0.34 Degrees | Standard Deviation 0.811 |
| Lateral Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 3 months | -0.231 Degrees | Standard Deviation 0.71 |
| Lateral Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 Weeks | -0.175 Degrees | Standard Deviation 0.612 |
| Lateral Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 months | 0.585 Degrees | Standard Deviation 1.043 |
| Lateral Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 1 year | -0.272 Degrees | Standard Deviation 1.774 |
| Lateral Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 weeks | 0.357 Degrees | Standard Deviation 0.588 |
| Lateral Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 2 years | -0.156 Degrees | Standard Deviation 1.406 |
| Lateral Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 months | 0.069 Degrees | Standard Deviation 0.575 |
| Lateral Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 1 year | -0.033 Degrees | Standard Deviation 0.636 |
| Lateral Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 weeks | 0.135 Degrees | Standard Deviation 0.384 |
| Lateral Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 1 year | 0.343 Degrees | Standard Deviation 1.467 |
| Anterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 1 year | 0.73 Degrees | Standard Deviation 0.738 |
| Anterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 Weeks | 0.059 Degrees | Standard Deviation 0.55 |
| Anterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 3 months | 0.054 Degrees | Standard Deviation 0.56 |
| Anterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 1 year | -0.306 Degrees | Standard Deviation 0.774 |
| Anterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 weeks | -0.033 Degrees | Standard Deviation 0.372 |
| Anterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 weeks | 0.026 Degrees | Standard Deviation 0.377 |
| Anterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 3 months | -0.201 Degrees | Standard Deviation 0.528 |
| Anterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 3 months | 0.343 Degrees | Standard Deviation 1.113 |
| Anterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 6 months | 0.481 Degrees | Standard Deviation 3.181 |
| Anterior Approach | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 months | -0.254 Degrees | Standard Deviation 1.693 |
| Anterior Approach | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 months | 0.549 Degrees | Standard Deviation 1.68 |
| Anterior Approach | Other RSA Measurements (Rotations) | X-axis Rotation at 1 year | -0.943 Degrees | Standard Deviation 0.773 |
| Overall Population | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 weeks | 0.059 Degrees | Standard Deviation 0.364 |
| Overall Population | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 weeks | 0.085 Degrees | Standard Deviation 0.487 |
| Overall Population | Other RSA Measurements (Rotations) | Y-axis Rotation at 1 year | 0.066 Degrees | Standard Deviation 1.049 |
| Overall Population | Other RSA Measurements (Rotations) | Y-axis Rotation at 6 months | 0.145 Degrees | Standard Deviation 1.238 |
| Overall Population | Other RSA Measurements (Rotations) | Z-axis Rotation at 2 years | 0.195 Degrees | Standard Deviation 0.739 |
| Overall Population | Other RSA Measurements (Rotations) | Y-axis Rotation at 2 years | 0.1 Degrees | Standard Deviation 1.019 |
| Overall Population | Other RSA Measurements (Rotations) | Y-axis Rotation at 3 months | 0.044 Degrees | Standard Deviation 1.102 |
| Overall Population | Other RSA Measurements (Rotations) | Z-axis Rotation at 6 months | 0.196 Degrees | Standard Deviation 1.01 |
| Overall Population | Other RSA Measurements (Rotations) | X-axis Rotation at 2 years | -0.072 Degrees | Standard Deviation 0.974 |
| Overall Population | Other RSA Measurements (Rotations) | Z-axis Rotation at 1 year | -0.018 Degrees | Standard Deviation 0.596 |
| Overall Population | Other RSA Measurements (Rotations) | X-axis Rotation at 6 Weeks | -0.009 Degrees | Standard Deviation 0.495 |
| Overall Population | Other RSA Measurements (Rotations) | Z-axis Rotation at 3 months | -0.013 Degrees | Standard Deviation 0.841 |
| Overall Population | Other RSA Measurements (Rotations) | X-axis Rotation at 3 months | -0.209 Degrees | Standard Deviation 0.974 |
| Overall Population | Other RSA Measurements (Rotations) | X-axis Rotation at 1 year | -0.069 Degrees | Standard Deviation 0.988 |
| Overall Population | Other RSA Measurements (Rotations) | X-axis Rotation at 6 months | -0.069 Degrees | Standard Deviation 1.789 |
Secondary
Other RSA Measurements (X-Translations)
Other RSA measurements (X translations in mm) at all time points
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 2 years | -0.057 mm | Standard Deviation 0.372 |
| Posterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 weeks | 0.009 mm | Standard Deviation 0.082 |
| Posterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 months | -0.001 mm | Standard Deviation 0.271 |
| Posterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 1 year | -0.029 mm | Standard Deviation 0.284 |
| Posterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 3 months | -0.085 mm | Standard Deviation 0.229 |
| Lateral Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 months | -0.02 mm | Standard Deviation 0.3 |
| Lateral Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 weeks | -0.016 mm | Standard Deviation 0.214 |
| Lateral Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 3 months | -0.042 mm | Standard Deviation 0.277 |
| Lateral Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 1 year | 0.06 mm | Standard Deviation 0.283 |
| Lateral Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 2 years | -0.026 mm | Standard Deviation 0.361 |
| Anterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 3 months | 0.028 mm | Standard Deviation 0.321 |
| Anterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 1 year | 0.146 mm | Standard Deviation 0.261 |
| Anterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 weeks | 0.049 mm | Standard Deviation 0.119 |
| Anterior Approach | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 months | 0.113 mm | Standard Deviation 0.402 |
| Overall Population | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 3 months | -0.033 mm | Standard Deviation 0.276 |
| Overall Population | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 1 year | 0.022 mm | Standard Deviation 0.282 |
| Overall Population | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 months | 0.025 mm | Standard Deviation 0.317 |
| Overall Population | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 6 weeks | 0.017 mm | Standard Deviation 0.134 |
| Overall Population | Other RSA Measurements (X-Translations) | X-axis translations (mm) at 2 years | -0.047 mm | Standard Deviation 0.363 |
Secondary
Other RSA Measurements (Z-Translations)
Other RSA measurements (Z translations in mm) at all time points
Time frame: At 6 weeks, 3 months, 6 months, 1 year, 2 years
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 months | -0.023 mm | Standard Deviation 0.303 |
| Posterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 2 years | -0.207 mm | Standard Deviation 0.344 |
| Posterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 1 year | -0.112 mm | Standard Deviation 0.234 |
| Posterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 3 months | -0.087 mm | Standard Deviation 0.317 |
| Posterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 weeks | -0.033 mm | Standard Deviation 0.134 |
| Lateral Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 3 months | -0.095 mm | Standard Deviation 0.379 |
| Lateral Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 months | -0.199 mm | Standard Deviation 0.341 |
| Lateral Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 1 year | 0.014 mm | Standard Deviation 0.41 |
| Lateral Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 weeks | -0.06 mm | Standard Deviation 0.15 |
| Lateral Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 2 years | -0.061 mm | Standard Deviation 0.466 |
| Anterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 1 year | -0.095 mm | Standard Deviation 0.462 |
| Anterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 weeks | -0.033 mm | Standard Deviation 0.227 |
| Anterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 3 months | 0.127 mm | Standard Deviation 0.409 |
| Anterior Approach | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 months | -0.004 mm | Standard Deviation 0.759 |
| Overall Population | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 1 year | -0.076 mm | Standard Deviation 0.325 |
| Overall Population | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 months | -0.063 mm | Standard Deviation 0.476 |
| Overall Population | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 6 weeks | -0.039 mm | Standard Deviation 0.172 |
| Overall Population | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 2 years | -0.161 mm | Standard Deviation 0.385 |
| Overall Population | Other RSA Measurements (Z-Translations) | Z-axis translations (mm) at 3 months | -0.013 mm | Standard Deviation 0.376 |
Secondary
Patient Reported Outcome Measures (PROMs)- Harris Hip Score
The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result.
Time frame: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Population: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 1 year follow-up | 94.93 Units on a scale | Standard Deviation 7.95 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 3 months follow-up | 90.08 Units on a scale | Standard Deviation 10.51 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 months follow-up | 91.09 Units on a scale | Standard Deviation 11.22 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at Pre-op | 57.6 Units on a scale | Standard Deviation 15.14 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 2 years follow-up | 93.27 Units on a scale | Standard Deviation 12.55 |
| Posterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 weeks follow-up | 82.14 Units on a scale | Standard Deviation 11.52 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 weeks follow-up | 76.67 Units on a scale | Standard Deviation 15.91 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 3 months follow-up | 89.00 Units on a scale | Standard Deviation 15.58 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at Pre-op | 49.47 Units on a scale | Standard Deviation 20.16 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 months follow-up | 93.89 Units on a scale | Standard Deviation 9.51 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 1 year follow-up | 96.27 Units on a scale | Standard Deviation 6.48 |
| Lateral Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 2 years follow-up | 95.44 Units on a scale | Standard Deviation 7.99 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 weeks follow-up | 86.00 Units on a scale | Standard Deviation 14.07 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at Pre-op | 61.23 Units on a scale | Standard Deviation 12.61 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 3 months follow-up | 93.18 Units on a scale | Standard Deviation 6.11 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 1 year follow-up | 100 Units on a scale | Standard Deviation 0 |
| Anterior Approach | Patient Reported Outcome Measures (PROMs)- Harris Hip Score | HHS at 6 months follow-up | 96.71 Units on a scale | Standard Deviation 5.5 |
Secondary
RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year
Time frame: At 3 months, 6 months and 1 year
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up | 0.065 mm | Standard Deviation 0.232 |
| Posterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up | 0.13 mm | Standard Deviation 0.314 |
| Posterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up | 0.044 mm | Standard Deviation 0.11 |
| Lateral Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up | 0.05 mm | Standard Deviation 0.377 |
| Lateral Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up | 0.047 mm | Standard Deviation 0.32 |
| Lateral Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up | -0.065 mm | Standard Deviation 0.103 |
| Anterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up | -0.12 mm | Standard Deviation 0.287 |
| Anterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up | -0.011 mm | Standard Deviation 0.192 |
| Anterior Approach | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up | -0.062 mm | Standard Deviation 0.272 |
| Overall Population | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up | 0.032 mm | Standard Deviation 0.286 |
| Overall Population | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up | -0.025 mm | Standard Deviation 0.187 |
| Overall Population | RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year | RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up | 0.07 mm | Standard Deviation 0.289 |