Non-inflammatory Degenerative Joint Disease
Conditions
Keywords
Hip arthroplasty, Acetabular cup replacement, Acetabulum arthroplasty
Brief summary
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Detailed description
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
Interventions
DEVICEASR™-XL Modular Acetabular Cup System
The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
DEVICEPinnacle™ acetabular shell
The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is able to or capable of providing consent to participate in the clinical investigation. * Subject is between the ages of 20-75 years, inclusive. * Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD). * Subject has sufficient bone stock for the hip replacement device. * Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.
Exclusion criteria
* Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation. * Subject with a known allergy to metal (e.g. jewelry). * Subject has inflammatory arthritis (e.g. rheumatoid arthritis). * Subject has active or recent joint sepsis. * Subject with marked atrophy or deformity in the upper femur. * Subject with a neuromuscular disease where the loss of musculature would affect functional outcome. * Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis). * Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery. * Subject with known, active metastatic or neoplastic disease. * Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser. * Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes | 24-month interval. | Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Pain Sub Score at 24 Months | 24 months | Mean Harris Hip Pain sub score |
| Harris Hip Function Score at 24 Months | 24 months | Mean Harris Hip Function sub score at 24 months |
| Analysis of Metal Ion Release - Serum Cobalt | Pre-operative | Serum Cobalt |
| T-Test of Harris Hip Total Score Means at 24 Months | 24 months | T-Test of Harris Hip total score means at 24 months |
| Analysis of Metal Ion Release - Erythrocyte Cobalt | pre-operative | Erythrocyte cobalt |
| Analysis of Metal Ion Release - Erythrocyte Chromium | Pre-operative | Erythrocyte Chromium |
| Analysis of Metal Ion Release - Serum Chromium | pre-operative | Serum Chromium |
Countries
United States
Participant flow
Recruitment details
Recruitment at orthopaedic clinics began Nov 2006 and ended Dec 2009
Participants by arm
| Arm | Count |
|---|---|
| ASR XL ASR™-XL Acetabular Cup System | 130 |
| Pinnacle MoM Pinnacle metal on metal acetabular cup system | 135 |
| Total | 265 |
Baseline characteristics
| Characteristic | ASR XL | Pinnacle MoM | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 8.6 | 59.4 years STANDARD_DEVIATION 9.4 | 59.6 years STANDARD_DEVIATION 9 |
| BMI | 29.7 lb/in^2 STANDARD_DEVIATION 7 | 30.1 lb/in^2 STANDARD_DEVIATION 6 | 29.9 lb/in^2 STANDARD_DEVIATION 6.5 |
| Region of Enrollment United States | 130 participants | 135 participants | 265 participants |
| Sex: Female, Male Female | 60 Participants | 51 Participants | 111 Participants |
| Sex: Female, Male Male | 70 Participants | 84 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 72 / 130 | 59 / 135 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months
Time frame: 24-month interval.
Population: Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASR XL Acetabular Cup System | Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes | 82 participants |
| Pinnacle Acetabular Cup System | Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes | 92 participants |
Comparison: A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.p-value: 0.872Chi-squared
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Time frame: 4 months post-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.45 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.50 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL groupp-value: 0.882Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte chromium
Time frame: 48 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.62 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.62 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL groupp-value: 0.957Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Time frame: Pre-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.55 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.62 ug/L |
p-value: 0.799Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte chromium
Time frame: 36 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.76 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.73 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL groupp-value: 0.689Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Time frame: 24 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 1.29 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 1.00 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL groupp-value: 0.3Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Chromium
Erythrocyte Chromium
Time frame: 12 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 1.12 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Chromium | 0.58 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL groupp-value: 0.121Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte cobalt
Time frame: 36 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 2.06 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 1.20 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.018Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Time frame: 24 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 1.61 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.63 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte cobalt
Time frame: pre-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.07 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.08 ug/L |
p-value: 0.869Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Time frame: 12 Months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.91 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.41 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Time frame: 4 months post-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.85 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 0.26 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL groupp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Erythrocyte Cobalt
Erythrocyte Cobalt
Time frame: 48 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 1.90 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Erythrocyte Cobalt | 1.18 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.061Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: 12 Months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.37 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.19 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL groupp-value: 0.237Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: 4 months post operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.38 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 0.72 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL groupp-value: 0.032Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: pre-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 0.12 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 0.12 ug/L |
p-value: 0.762Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: 24 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 2.30 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.48 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL groupp-value: 0.103Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: 36 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.80 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.57 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL groupp-value: 0.766Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Chromium
Serum Chromium
Time frame: 48 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 2.04 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Chromium | 1.66 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL groupp-value: 0.782Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: 24 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 3.26 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 1.15 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.012Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: 36 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 3.17 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 2.19 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.079Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: 12 months post-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 1.55 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 0.98 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.005Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: Pre-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 0.10 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 0.10 ug/L |
p-value: 0.457Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: 4 months post-operative
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 1.39 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 0.51 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL groupp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Analysis of Metal Ion Release - Serum Cobalt
Serum Cobalt
Time frame: 48 months
Population: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASR XL Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 3.16 ug/L |
| Pinnacle Acetabular Cup System | Analysis of Metal Ion Release - Serum Cobalt | 1.83 ug/L |
Comparison: HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL groupp-value: 0.048Wilcoxon (Mann-Whitney)
Secondary
Harris Hip Function Score at 24 Months
Mean Harris Hip Function sub score at 24 months
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASR XL Acetabular Cup System | Harris Hip Function Score at 24 Months | 31.4 units on a scale 0-47. 47 is best | Standard Deviation 3.6 |
| Pinnacle Acetabular Cup System | Harris Hip Function Score at 24 Months | 31.6 units on a scale 0-47. 47 is best | Standard Deviation 3.7 |
Secondary
Harris Hip Pain Sub Score at 24 Months
Mean Harris Hip Pain sub score
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASR XL Acetabular Cup System | Harris Hip Pain Sub Score at 24 Months | 41.5 units on scale of 0-44. 44 is best | Standard Deviation 6 |
| Pinnacle Acetabular Cup System | Harris Hip Pain Sub Score at 24 Months | 42.7 units on scale of 0-44. 44 is best | Standard Deviation 3.3 |
Secondary
T-Test of Harris Hip Total Score Means at 24 Months
T-Test of Harris Hip total score means at 24 months
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASR XL Acetabular Cup System | T-Test of Harris Hip Total Score Means at 24 Months | 94.8 Units on a scale of 0-100,100 is best. | Standard Deviation 9.4 |
| Pinnacle Acetabular Cup System | T-Test of Harris Hip Total Score Means at 24 Months | 96.4 Units on a scale of 0-100,100 is best. | Standard Deviation 6.4 |
p-value: 0.167t-test, 2 sided