Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

• Sponsor: DePuy Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00561600
• Collaborator: (none)
• Enrollment: 265
• Locations: 8
• Arms: 2
• Actual Duration (Months): 62
• Patients Per Site: 33.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-inflammatory Degenerative Joint Disease	Device: ASR™-XL Modular Acetabular Cup System; Device: Pinnacle™ acetabular shell	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study
• Actual Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A ASR™-XL Modular Acetabular Cup System stem	Device: ASR™-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.; Other Names: Acetabular cup replacement
Active Comparator: B Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.	Device: Pinnacle™ 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.; Other Names: Acetabular cup replacement

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. T-Test of Harris Hip Total Score Means at 24 Months [24 months]

   T-Test of Harris Hip total score means at 24 months

2. Harris Hip Pain Sub Score at 24 Months [24 months]

   Mean Harris Hip Pain sub score

3. Harris Hip Function Score at 24 Months [24 months]

   Mean Harris Hip Function sub score at 24 months

4. Analysis of Metal Ion Release - Serum Cobalt [Pre-operative]

   Serum Cobalt

5. Analysis of Metal Ion Release - Serum Chromium [pre-operative]

   Serum Chromium

6. Analysis of Metal Ion Release - Erythrocyte Cobalt [pre-operative]

   Erythrocyte cobalt

7. Analysis of Metal Ion Release - Erythrocyte Chromium [Pre-operative]

   Erythrocyte Chromium

8. Analysis of Metal Ion Release - Serum Cobalt [4 months post-operative]

   Serum Cobalt

9. Analysis of Metal Ion Release - Serum Chromium [4 months post operative]

   Serum Chromium

10. Analysis of Metal Ion Release - Erythrocyte Cobalt [4 months post-operative]

    Erythrocyte Cobalt

11. Analysis of Metal Ion Release - Erythrocyte Chromium [4 months post-operative]

    Erythrocyte Chromium

12. Analysis of Metal Ion Release - Serum Cobalt [12 months post-operative]

    Serum Cobalt

13. Analysis of Metal Ion Release - Serum Chromium [12 Months]

    Serum Chromium

14. Analysis of Metal Ion Release - Erythrocyte Cobalt [12 Months]

    Erythrocyte Cobalt

15. Analysis of Metal Ion Release - Erythrocyte Chromium [12 months]

    Erythrocyte Chromium

16. Analysis of Metal Ion Release - Serum Cobalt [24 months]

    Serum Cobalt

17. Analysis of Metal Ion Release - Serum Chromium [24 months]

    Serum Chromium

18. Analysis of Metal Ion Release - Erythrocyte Cobalt [24 months]

    Erythrocyte Cobalt

19. Analysis of Metal Ion Release - Erythrocyte Chromium [24 months]

    Erythrocyte Chromium

20. Analysis of Metal Ion Release - Serum Cobalt [36 months]

    Serum Cobalt

21. Analysis of Metal Ion Release - Serum Chromium [36 months]

    Serum Chromium

22. Analysis of Metal Ion Release - Erythrocyte Cobalt [36 months]

    Erythrocyte cobalt

23. Analysis of Metal Ion Release - Erythrocyte Chromium [36 months]

    Erythrocyte chromium

24. Analysis of Metal Ion Release - Serum Cobalt [48 months]

    Serum Cobalt

25. Analysis of Metal Ion Release - Serum Chromium [48 months]

    Serum Chromium

26. Analysis of Metal Ion Release - Erythrocyte Cobalt [48 months]

    Erythrocyte Cobalt

27. Analysis of Metal Ion Release - Erythrocyte Chromium [48 months]

    Erythrocyte chromium

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Desert Orthopaedics	Rancho Mirage	California	United States	92270
2	Resurgens Orthopaedics	Cumming	Georgia	United States	30041
3	Illinois Bone and Joint Institute	Morton Grove	Illinois	United States	60053
4	Spectrum Health Hospital Research	Grand Rapids	Michigan	United States	49503-2550
5	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0001
6	Eastern Oklahoma Orthopedic Center	Tulsa	Oklahoma	United States	74136
7	Orthopaedic Specialists of Austin	Austin	Texas	United States	78705
8	Valley Orthopaedic Associates	Renton	Washington	United States	98055-5791

Sponsors and Collaborators

• DePuy Orthopaedics

Investigators

• Study Director: Dave Whalen, BS, DC, DePuy Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT00561600
• Other Study ID Numbers: 04062
• First Posted: Nov 21, 2007
• Last Update Posted: Aug 9, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by DePuy Orthopaedics: Hip arthroplasty; Acetabular cup replacement; Acetabulum arthroplasty
• Additional relevant MeSH terms: Joint Diseases; Osteoarthritis

Study Results

Participant Flow

Recruitment Details	Recruitment at orthopaedic clinics began Nov 2006 and ended Dec 2009

Arm/Group Title	A ASR™-XL	B Pinnacle™
Arm/Group Description	ASR™-XL Modular Acetabular Cup System stem	Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
Period Title: Overall Study
STARTED	130	135
COMPLETED	112	119
NOT COMPLETED	18	16

Baseline Characteristics

Arm/Group Title	ASR XL	Pinnacle MoM	Total
Arm/Group Description	ASR™-XL Acetabular Cup System	Pinnacle metal on metal acetabular cup system	Total of all reporting groups
Overall Participants	130	135	265
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.7 (8.6)	59.4 (9.4)	59.6 (9.0)
Sex: Female, Male (Count of Participants)
Female	60 46.2%	51 37.8%	111 41.9%
Male	70 53.8%	84 62.2%	154 58.1%
Region of Enrollment (participants) [Number]
United States	130 100%	135 100%	265 100%
BMI (lb/in^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lb/in^2]	29.7 (7.0)	30.1 (6.0)	29.9 (6.5)

Outcome Measures

1. Primary Outcome

Title	Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
Description	"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.

Outcome Measure Data

Analysis Population Description

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/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	110	104
Number [participants]	82 63.1%	92 68.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	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.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	non inferiority of proportion successful with 8% non inferiority margin at 24 months
Statistical Test of Hypothesis	p-Value	0.872
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	.139
	Confidence Interval	(1-Sided) 95%; to .225
	Parameter Dispersion	Type: Value:
	Estimation Comments	The upper confidence limit was a priori determined to be a secondary endpoint

2. Secondary Outcome

Title	T-Test of Harris Hip Total Score Means at 24 Months
Description	T-Test of Harris Hip total score means at 24 months
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	110	105
Mean (Standard Deviation) [Units on a scale of 0-100,100 is best.]	94.8 (9.4)	96.4 (6.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.167
	Comments
	Method	t-test, 2 sided
	Comments	Satterthwaite

3. Secondary Outcome

Title	Harris Hip Pain Sub Score at 24 Months
Description	Mean Harris Hip Pain sub score
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	110	106
Mean (Standard Deviation) [units on scale of 0-44. 44 is best]	41.5 (6.0)	42.7 (3.3)

4. Secondary Outcome

Title	Harris Hip Function Score at 24 Months
Description	Mean Harris Hip Function sub score at 24 months
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	110	105
Mean (Standard Deviation) [units on a scale 0-47. 47 is best]	31.4 (3.6)	31.6 (3.7)

5. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	Pre-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	31	32
Median (Full Range) [ug/L]	0.10	0.10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.457
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	31	32
Median (Full Range) [ug/L]	0.12	0.12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.762
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte cobalt
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	31	32
Median (Full Range) [ug/L]	0.07	0.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.869
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte Chromium
Time Frame	Pre-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	31	32
Median (Full Range) [ug/L]	0.55	0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.799
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	4 months post-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	32	29
Median (Full Range) [ug/L]	1.39	0.51

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	4 months post operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	32	29
Median (Full Range) [ug/L]	1.38	0.72

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte Cobalt
Time Frame	4 months post-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	32	28
Median (Full Range) [ug/L]	0.85	0.26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte Chromium
Time Frame	4 months post-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	32	28
Median (Full Range) [ug/L]	0.45	0.50

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.882
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	12 months post-operative

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL	Pinnacle MoM
Arm/Group Description	ASR™-XL Acetabular Cup System	Pinnacle metal on metal acetabular cup system
Measure Participants	30	30
Median (Full Range) [ug/L]	1.55	0.98

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	30
Median (Full Range) [ug/L]	1.37	1.19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.237
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte Cobalt
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	30
Median (Full Range) [ug/L]	0.91	0.41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte Chromium
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	30
Median (Full Range) [ug/L]	1.12	0.58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.121
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	25	21
Median (Full Range) [ug/L]	3.26	1.15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	25	21
Median (Full Range) [ug/L]	2.30	1.48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.103
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

19. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte Cobalt
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	25	21
Median (Full Range) [ug/L]	1.61	0.63

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

20. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte Chromium
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	25	21
Median (Full Range) [ug/L]	1.29	1.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.300
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

21. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	19
Median (Full Range) [ug/L]	3.17	2.19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.079
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

22. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	19
Median (Full Range) [ug/L]	1.80	1.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.766
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

23. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte cobalt
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	19
Median (Full Range) [ug/L]	2.06	1.20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

24. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte chromium
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	30	19
Median (Full Range) [ug/L]	0.76	0.73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.689
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

25. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Cobalt
Description	Serum Cobalt
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	15	13
Median (Full Range) [ug/L]	3.16	1.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

26. Secondary Outcome

Title	Analysis of Metal Ion Release - Serum Chromium
Description	Serum Chromium
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	15	13
Median (Full Range) [ug/L]	2.04	1.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.782
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

27. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Cobalt
Description	Erythrocyte Cobalt
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	13	12
Median (Full Range) [ug/L]	1.90	1.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

28. Secondary Outcome

Title	Analysis of Metal Ion Release - Erythrocyte Chromium
Description	Erythrocyte chromium
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Arm/Group Title	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup System
Arm/Group Description
Measure Participants	13	12
Median (Full Range) [ug/L]	0.62	0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ASR XL Acetabular Cup System, Pinnacle Acetabular Cup System
	Comments	HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.957
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
Arm/Group Title	ASR XL Acetabular Cup System		Pinnacle Acetabular Cup System
Arm/Group Description
All Cause Mortality
	ASR XL Acetabular Cup System		Pinnacle Acetabular Cup System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ASR XL Acetabular Cup System		Pinnacle Acetabular Cup System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	ASR XL Acetabular Cup System		Pinnacle Acetabular Cup System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	72/130 (55.4%)		59/135 (43.7%)
Cardiac disorders
Atrial fibrillation	1/130 (0.8%)	1	3/135 (2.2%)	3
Atrial flutter	1/130 (0.8%)	1	0/135 (0%)	0
Cardiac failure	0/130 (0%)	0	1/135 (0.7%)	1
Coronary artery occlusion	0/130 (0%)	0	1/135 (0.7%)	1
Myocardial infarction	2/130 (1.5%)	2	1/135 (0.7%)	1
Sinus tachycardia	1/130 (0.8%)	1	0/135 (0%)	0
Tachycardia	0/130 (0%)	0	1/135 (0.7%)	1
Congenital, familial and genetic disorders
Hip dysplasia	0/130 (0%)	0	1/135 (0.7%)	1
Gastrointestinal disorders
Abdominal pain	0/130 (0%)	0	1/135 (0.7%)	1
Colitis	1/130 (0.8%)	1	0/135 (0%)	0
Ileus	0/130 (0%)	0	1/135 (0.7%)	1
Pancreatitis	1/130 (0.8%)	2	1/135 (0.7%)	1
General disorders
Asthenia	0/130 (0%)	0	1/135 (0.7%)	1
Death	1/130 (0.8%)	1	0/135 (0%)	0
Device component issue	6/130 (4.6%)	7	0/135 (0%)	0
Device dislocation	0/130 (0%)	0	1/135 (0.7%)	1
Medical device complication	0/130 (0%)	0	1/135 (0.7%)	1
Medical device site reaction	5/130 (3.8%)	5	1/135 (0.7%)	1
Pain	4/130 (3.1%)	4	2/135 (1.5%)	2
Adverse drug reaction	1/130 (0.8%)	1	0/135 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/130 (0%)	0	1/135 (0.7%)	1
Immune system disorders
Multiple sclerosis	1/130 (0.8%)	1	0/135 (0%)	0
Infections and infestations
Abscess	0/130 (0%)	0	1/135 (0.7%)	1
Cellulitis	1/130 (0.8%)	1	1/135 (0.7%)	2
Infection	1/130 (0.8%)	1	3/135 (2.2%)	5
Laryngitis	0/130 (0%)	0	1/135 (0.7%)	1
Oral candidacies	1/130 (0.8%)	1	0/135 (0%)	0
Pneumonia	1/130 (0.8%)	1	0/135 (0%)	0
Tooth abscess	0/130 (0%)	0	1/135 (0.7%)	1
Urinary tract infection	1/130 (0.8%)	1	1/135 (0.7%)	1
Injury, poisoning and procedural complications
Fracture	3/130 (2.3%)	4	1/135 (0.7%)	1
Gun shot wound	0/130 (0%)	0	1/135 (0.7%)	1
Iliotibial band syndrome	2/130 (1.5%)	3	2/135 (1.5%)	2
Laceration	0/130 (0%)	0	3/135 (2.2%)	3
Ligament sprain	1/130 (0.8%)	2	0/135 (0%)	0
Meniscus injury	2/130 (1.5%)	2	0/135 (0%)	0
Muscle strain	1/130 (0.8%)	1	2/135 (1.5%)	2
Postoperative heterotopic calcification	0/130 (0%)	0	1/135 (0.7%)	1
Procedural pain	1/130 (0.8%)	1	0/135 (0%)	0
Radius fracture	1/130 (0.8%)	1	0/135 (0%)	0
Wound complication	2/130 (1.5%)	3	4/135 (3%)	5
Epicondylitis	1/130 (0.8%)	1	0/135 (0%)	0
Investigations
Blood heavy metal increased	4/130 (3.1%)	4	0/135 (0%)	0
Hematocrit decreased	0/130 (0%)	0	1/135 (0.7%)	1
White blood cell increased	0/130 (0%)	0	1/135 (0.7%)	1
Metabolism and nutrition disorders
Gout	0/130 (0%)	0	1/135 (0.7%)	2
Hypokalemia	1/130 (0.8%)	1	0/135 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	9/130 (6.9%)	20	11/135 (8.1%)	15
Arthralgia joint swelling	1/130 (0.8%)	1	0/135 (0%)	0
Arthritis	1/130 (0.8%)	1	1/135 (0.7%)	1
Back disorder	0/130 (0%)	0	1/135 (0.7%)	1
Back pain	5/130 (3.8%)	5	6/135 (4.4%)	6
Bone loss	1/130 (0.8%)	1	0/135 (0%)	0
Bursitis	12/130 (9.2%)	19	8/135 (5.9%)	10
Groin pain	5/130 (3.8%)	6	3/135 (2.2%)	5
Intervertebral disc protrusion	1/130 (0.8%)	1	0/135 (0%)	0
Joint crepitation	0/130 (0%)	0	1/135 (0.7%)	1
Joint lock	1/130 (0.8%)	1	0/135 (0%)	0
Joint swelling	1/130 (0.8%)	1	0/135 (0%)	0
Muscle disorder	0/130 (0%)	0	1/135 (0.7%)	1
Muscular weakness	0/130 (0%)	0	1/135 (0.7%)	1
Musculoskeletal discomfort	1/130 (0.8%)	1	0/135 (0%)	0
Musculoskeletal pain	1/130 (0.8%)	1	1/135 (0.7%)	1
Myalgia	3/130 (2.3%)	3	0/135 (0%)	0
Myositis	0/130 (0%)	0	1/135 (0.7%)	1
Osteoarthritis	8/130 (6.2%)	11	7/135 (5.2%)	9
Pain in extremity	2/130 (1.5%)	3	1/135 (0.7%)	1
Pathological fracture	1/130 (0.8%)	1	0/135 (0%)	0
Plantar Fascitis	0/130 (0%)	0	1/135 (0.7%)	1
Rheumatoid arthritis	1/130 (0.8%)	1	0/135 (0%)	0
Rotataor cuff syndrome	1/130 (0.8%)	1	0/135 (0%)	0
Spinal column stenosis	1/130 (0.8%)	1	0/135 (0%)	0
Spondylolisthesis	1/130 (0.8%)	2	0/135 (0%)	0
Tendonitis	2/130 (1.5%)	2	2/135 (1.5%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/130 (0%)	0	2/135 (1.5%)	2
Breast cancer	0/130 (0%)	0	2/135 (1.5%)	2
Lung cancer metastatic	1/130 (0.8%)	2	0/135 (0%)	0
Neoplasm malignant	1/130 (0.8%)	1	0/135 (0%)	0
Prostate cancer	1/130 (0.8%)	1	1/135 (0.7%)	1
Nervous system disorders
Carpal tunnel syndrome	0/130 (0%)	0	1/135 (0.7%)	1
Paresthesia	0/130 (0%)	0	2/135 (1.5%)	2
Piriformis syndrome	1/130 (0.8%)	1	0/135 (0%)	0
Sciatica	2/130 (1.5%)	2	0/135 (0%)	0
Psychiatric disorders
Anxiety	1/130 (0.8%)	1	0/135 (0%)	0
Renal and urinary disorders
Renal failure acute	1/130 (0.8%)	1	0/135 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chest discomfort	0/130 (0%)	0	1/135 (0.7%)	1
Pulmonary embolism	0/130 (0%)	0	1/135 (0.7%)	1
Pulmonary fibrosis	0/130 (0%)	0	1/135 (0.7%)	2
Pulmonary mass	1/130 (0.8%)	1	0/135 (0%)	0
Skin and subcutaneous tissue disorders
Rash	2/130 (1.5%)	2	0/135 (0%)	0
Surgical and medical procedures
Angioplasty	1/130 (0.8%)	1	1/135 (0.7%)	1
Hip arthroplasty	5/130 (3.8%)	6	3/135 (2.2%)	3
Knee arthroplasty	2/130 (1.5%)	3	1/135 (0.7%)	1
Knee operation	0/130 (0%)	0	1/135 (0.7%)	1
Post procedural drainage	0/130 (0%)	0	1/135 (0.7%)	1
Shoulder operation	1/130 (0.8%)	1	0/135 (0%)	0
Vascular disorders
Aortic aneurysm	0/130 (0%)	0	1/135 (0.7%)	1
Haematoma	1/130 (0.8%)	1	0/135 (0%)	0
Hypertension	0/130 (0%)	0	1/135 (0.7%)	1
Hypotension	2/130 (1.5%)	2	0/135 (0%)	0
Varicose vein	0/130 (0%)	0	1/135 (0.7%)	1

Limitations/Caveats

At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.