Arthroplasty, Replacement, Hip
Conditions
Keywords
Noninflammatory joint disease of the hip.
Brief summary
The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.
Detailed description
This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component. Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.
Interventions
DEVICERestoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form. * Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation. * Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). * Patient is a candidate for a primary cementless acetabular replacement. * Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
* Patient has a Body Mass Index (BMI) ≥ 40. * Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. * Patient has a known sensitivity to device materials. * Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 10 years postoperative | Defined as absence of postoperative femoral head dislocation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System | 10 years | Revision or removal of any study component. |
| Patient Satisfaction and Pain: Follow-up Questionnaire | 6-10 years | This questionnaire will be used to obtain the following information: * Satisfaction with the hip replacement * Presence of any pain in the study hip * Surgeries performed on the study hip * Any dislocations in the study hip |
| Radiographic Stability Rates | 6 week,1, 2, 3, 4, 5 years | Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points. |
| Complication Rates for Psoas Impingement and Associated Groin Pain | 10 years | Reported occurrence of any participant/hip experiencing groin pain or psoas impingement. |
| Harris Hip Score (HHS) Score Improvement From Preoperative Score | pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional. | The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor |
| Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | preop, 6 week, 1,2,3,4,5 years | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
| EQ-5D Index Score Improvement From Preoperative Score | preop, 6 week, 1,2,3,4,5 years | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health, and a high score shows better health. |
| Percentage of Cases Which Did Not Have Any Component Revised | 10 years | The number of hips that did not undergo a removal/revision of any of the hip components. |
| Short Form-12 (SF-12) Improvement From Preoperative Score | preop, 6 week, 1,2,3,4,5 years | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
There were 390 hips in 367 participants that were enrolled in the study. (23 bilateral cases).
Pre-assignment details
Of the 390 hips/367 participants enrolled there were 36 hips/34 participants censored due to not having the study device, surgery canceled or an inclusion exclusion violation so 354 hips/333 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.
Participants by arm
| Arm | Count |
|---|---|
| Restoration ADM X3 Device Restoration ADM X3 Device in total hip replacement.
Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement. | 333 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Censored because of Inclusion Exclusion Violation | 11 |
| Overall Study | Censored because study device not implanted | 21 |
| Overall Study | Censored because surgery not performed | 2 |
| Overall Study | Death | 13 |
| Overall Study | Investigative Site Termination | 43 |
| Overall Study | Lost to Follow-up | 32 |
| Overall Study | Sponsor terminated study early | 127 |
| Overall Study | Withdrawal by Subject | 41 |
Baseline characteristics
| Characteristic | Restoration ADM X3 Device |
|---|---|
| Age, Continuous Mean age | 60.99 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 315 Participants |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 354 | 13 / 333 |
| other Total, other adverse events | 56 / 354 | 0 / 333 |
| serious Total, serious adverse events | 15 / 354 | 66 / 333 |
Outcome results
Primary
Success Rate
Defined as absence of postoperative femoral head dislocation.
Time frame: 10 years postoperative
Population: Participants/hips with available data up to 10 years or at the time of early study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration ADM X3 Device | Success Rate | 354 hips |
Secondary
All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
Revision or removal of any study component.
Time frame: 10 years
Population: Includes all participants who received the study device and were not censored from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration ADM X3 Device | All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System | 12 hips |
Secondary
Complication Rates for Psoas Impingement and Associated Groin Pain
Reported occurrence of any participant/hip experiencing groin pain or psoas impingement.
Time frame: 10 years
Population: Participants/hips that reported an event of groin pain or psoas impingement up until early study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration ADM X3 Device | Complication Rates for Psoas Impingement and Associated Groin Pain | 2 hips |
Secondary
EQ-5D Index Score Improvement From Preoperative Score
The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health, and a high score shows better health.
Time frame: preop, 6 week, 1,2,3,4,5 years
Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D Pre-op | 67.22 score on a scale | Standard Deviation 19.16 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 6 weeks | 78.58 score on a scale | Standard Deviation 15.53 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 1-year | 82.9 score on a scale | Standard Deviation 13.76 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 2-years | 83.89 score on a scale | Standard Deviation 13.14 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 3-years | 84.14 score on a scale | Standard Deviation 12.29 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 4-years | 83.18 score on a scale | Standard Deviation 12.54 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 5-years | 81.26 score on a scale | Standard Deviation 14.63 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 7-years | 80.5 score on a scale | Standard Deviation 16.21 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D 10-years | 81.58 score on a scale | Standard Deviation 21.09 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | E-5D TTO Pre-op | 0.63 score on a scale | Standard Deviation 0.19 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 6 weeks | 0.81 score on a scale | Standard Deviation 0.15 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 1-year | 0.89 score on a scale | Standard Deviation 0.13 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 2-years | 0.90 score on a scale | Standard Deviation 0.13 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 3-years | 0.91 score on a scale | Standard Deviation 0.13 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 4-years | 0.9 score on a scale | Standard Deviation 0.13 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 5-years | 0.89 score on a scale | Standard Deviation 0.15 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 7-years | 0.9 score on a scale | Standard Deviation 0.13 |
| Restoration ADM X3 Device | EQ-5D Index Score Improvement From Preoperative Score | EQ-5D TTO 10-years | 0.92 score on a scale | Standard Deviation 0.17 |
Secondary
Harris Hip Score (HHS) Score Improvement From Preoperative Score
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Time frame: pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional.
Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | Preoperative | 54.47 score on a scale | Standard Deviation 12.85 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 6 weeks | 79.56 score on a scale | Standard Deviation 14.03 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 1 year | 92.32 score on a scale | Standard Deviation 10.44 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 2 years | 92.99 score on a scale | Standard Deviation 10.35 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 3 years | 94.80 score on a scale | Standard Deviation 9 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 4 years | 94.22 score on a scale | Standard Deviation 9.06 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 5 years | 95.66 score on a scale | Standard Deviation 6.69 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 7 years | 93.77 score on a scale | Standard Deviation 9.22 |
| Restoration ADM X3 Device | Harris Hip Score (HHS) Score Improvement From Preoperative Score | 10 years | 95.43 score on a scale | Standard Deviation 7.67 |
Secondary
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: preop, 6 week, 1,2,3,4,5 years
Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | Pre-op | 9.2 score on a scale | Standard Deviation 3.06 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 6 weeks | 8.94 score on a scale | Standard Deviation 2.59 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 1-year | 11.49 score on a scale | Standard Deviation 2.94 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 2-years | 11.79 score on a scale | Standard Deviation 3.09 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 3-years | 11.82 score on a scale | Standard Deviation 2.96 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 4-years | 11.66 score on a scale | Standard Deviation 2.99 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 5-years | 11.62 score on a scale | Standard Deviation 2.99 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 7-years | 11.3 score on a scale | Standard Deviation 3.17 |
| Restoration ADM X3 Device | Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score | 10-years | 10.84 score on a scale | Standard Deviation 3.21 |
Secondary
Patient Satisfaction and Pain: Follow-up Questionnaire
This questionnaire will be used to obtain the following information: * Satisfaction with the hip replacement * Presence of any pain in the study hip * Surgeries performed on the study hip * Any dislocations in the study hip
Time frame: 6-10 years
Population: Participants/hips with available data at the 6,7,8.9.10 years postoperative.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 6 years - Yes | 25 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 6 years - No | 172 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 6 years - Yes | 191 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 6 years - No | 4 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 6 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 6 years - No | 197 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 6 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 6 years - No | 197 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 7 years - Yes | 22 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 7 years - No | 141 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 7 years - Yes | 162 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 7 years - No | 1 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 7 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 7 years - No | 163 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 7 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 7 years - No | 163 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 8 years - Yes | 12 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 8 years - No | 117 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 8 years - Yes | 128 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 8 years - No | 1 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 8 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 8 years - No | 129 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 8 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 8 years - No | 129 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 9 years - Yes | 8 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 9 years - No | 73 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 9 years - Yes | 79 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 9 years - No | 1 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 9 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 9 years - No | 80 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 9 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 9 years - No | 80 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 10 years - Yes | 8 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Presence of any pain in the study hip at 10 years - No | 62 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 10 years - Yes | 69 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Satisfaction with the hip replacement at 10 years - No | 1 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 10 years - Yes | 1 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Surgeries performed on the study hip at 10 years - No | 69 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 10 years - Yes | 0 hips |
| Restoration ADM X3 Device | Patient Satisfaction and Pain: Follow-up Questionnaire | Any dislocations in the study hip at 10 years - No | 70 hips |
Secondary
Percentage of Cases Which Did Not Have Any Component Revised
The number of hips that did not undergo a removal/revision of any of the hip components.
Time frame: 10 years
Population: Participants/hips with available data at 10 years or at the time of early study termination. There were 12 hip revisions of the 354 hips in the study, leaving 342 hip cases without a revision of any components.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration ADM X3 Device | Percentage of Cases Which Did Not Have Any Component Revised | 342 hips |
Secondary
Radiographic Stability Rates
Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points.
Time frame: 6 week,1, 2, 3, 4, 5 years
Population: Participants/hips with available radiographic data submitted at the outcome measure time frames.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration ADM X3 Device | Radiographic Stability Rates | 0 hips |
Secondary
Short Form-12 (SF-12) Improvement From Preoperative Score
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: preop, 6 week, 1,2,3,4,5 years
Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | Pre-op Physical Component | 32.62 score on a scale | Standard Deviation 8.94 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 6 weeks Physical Component | 40.02 score on a scale | Standard Deviation 8.49 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 1-year Physical Component | 48.43 score on a scale | Standard Deviation 9.6 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 2-years Physical Component | 49.44 score on a scale | Standard Deviation 8.63 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 3-years Physical Component | 49.69 score on a scale | Standard Deviation 8.79 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 4-years Physical Component | 48.93 score on a scale | Standard Deviation 9.31 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 5-years Physical Component | 48.49 score on a scale | Standard Deviation 9.73 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 7-years Physical Component | 48.45 score on a scale | Standard Deviation 9.39 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 10-years Physical Component | 49.26 score on a scale | Standard Deviation 8.86 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | Pre-op Mental Component | 52.42 score on a scale | Standard Deviation 10.99 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 6 weeks Mental Component | 55.18 score on a scale | Standard Deviation 9.33 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 1-year Mental Component | 55.2 score on a scale | Standard Deviation 7.61 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 2-years Mental Component | 54.88 score on a scale | Standard Deviation 7.8 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 3-years Mental Component | 54.92 score on a scale | Standard Deviation 7.69 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 4-years Mental Component | 55.85 score on a scale | Standard Deviation 6.95 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 5-years Mental Component | 55.29 score on a scale | Standard Deviation 7.81 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 7-years Mental Component | 55.53 score on a scale | Standard Deviation 7.94 |
| Restoration ADM X3 Device | Short Form-12 (SF-12) Improvement From Preoperative Score | 10-years Mental Component | 55.73 score on a scale | Standard Deviation 8.4 |