Trial Outcomes & Findings for Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS) (NCT NCT02096211)
NCT ID: NCT02096211
Last Updated: 2025-07-16
Results Overview
Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
5 years
Results posted on
2025-07-16
Participant Flow
All eligible patients were asked if they were interested in study participation
Unit of analysis: Implants
Participant milestones
| Measure |
CERAMAX COC 36mm Acetabular Cup
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Overall Study
STARTED
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170 172
|
|
Overall Study
COMPLETED
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110 110
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|
Overall Study
NOT COMPLETED
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60 62
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Reasons for withdrawal
| Measure |
CERAMAX COC 36mm Acetabular Cup
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Overall Study
Death
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2
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Overall Study
Withdrawal by Subject
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8
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Overall Study
Revision of implant
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7
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Overall Study
Lost to Follow-up
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43
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Baseline Characteristics
All study participants (n=170)
Baseline characteristics by cohort
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=170 Participants
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Age, Continuous
Participant Age
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53.6 Years
STANDARD_DEVIATION 10.65 • n=5 Participants • All study participants (n=170)
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|
Sex: Female, Male
Female
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70 Participants
n=5 Participants • Study Participant Gender
|
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Sex: Female, Male
Male
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100 Participants
n=5 Participants • Study Participant Gender
|
|
Ethnicity (NIH/OMB)
Study Participant Ethnicity · Hispanic or Latino
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2 Participants
n=5 Participants • Study Participants
|
|
Ethnicity (NIH/OMB)
Study Participant Ethnicity · Not Hispanic or Latino
|
168 Participants
n=5 Participants • Study Participants
|
|
Ethnicity (NIH/OMB)
Study Participant Ethnicity · Unknown or Not Reported
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0 Participants
n=5 Participants • Study Participants
|
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Race (NIH/OMB)
Study Participant Race · American Indian or Alaska Native
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1 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · Asian
|
0 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · Black or African American
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26 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · White
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143 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · More than one race
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0 Participants
n=5 Participants • Study Participants
|
|
Race (NIH/OMB)
Study Participant Race · Unknown or Not Reported
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0 Participants
n=5 Participants • Study Participants
|
|
Study Participant Primary Diagnosis
Osteoarthritis
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144 Participants
n=5 Participants • Study Participants
|
|
Study Participant Primary Diagnosis
Avascular Necrosis
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22 Participants
n=5 Participants • Study Participants
|
|
Study Participant Primary Diagnosis
Post Traumatic Arthritis
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4 Participants
n=5 Participants • Study Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All Study Participants
Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=172 Implants
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Post-Operative 5-Year Device Survivorship
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95.3 Percentage of implants
Interval 90.8 to 97.6
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SECONDARY outcome
Timeframe: Years 1 through 6 post-operativelyPopulation: All study participants
Device survivorship at each year post-operative was a secondary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided for each post-operative year.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=172 Implants
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 1 year with 164 hips remaining
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97.7 Percentage of implants
Interval 93.9 to 99.1
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Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 2 years with 161 hips remaining
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96.5 Percentage of implants
Interval 92.3 to 98.4
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|
Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 3 years with 158 hips remaining
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95.9 Percentage of implants
Interval 91.6 to 98.0
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|
Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 4 years with 154 hips remaining
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95.3 Percentage of implants
Interval 90.8 to 97.6
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Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 5 years with 150 hips remaining
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95.3 Percentage of implants
Interval 90.8 to 97.6
|
|
Kaplan Meier Device Survivorship at Years 1 Through 6
Kaplan Meier device survivorship at 6 years with 58 hips remaining
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95.3 Percentage of implants
Interval 90.8 to 97.6
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SECONDARY outcome
Timeframe: Annually through 5 yearsPopulation: All study participants who attended their annual clinical evaluation
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=128 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Annual Total Harris Hip Score
Harris Hip score at 1 year Number of participants with Excellent Scores (90-100)
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98 Participant hips
Interval 12.18 to
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Annual Total Harris Hip Score
Harris Hip score at 1 year Number of participants with Good Scores (80-89)
|
18 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 1 year Number of participants with Fair Scores (70-79)
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4 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 1 year Number of participants with Poor Scores (Less than 70)
|
8 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 2 years. Number of participants with Excellent Scores (90-100)
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90 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 2 years. Number of participants with Good Scores (80-89)
|
20 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 2 years. Number of participants with Fair Scores (70-79)
|
6 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 2 years. Number of participants with Poor Scores (Less than 70)
|
7 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 3 years. Number of participants with Excellent Scores (90-100)
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50 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 3 years. Number of participants with Good Scores (80-89)
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5 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 3 years. Number of participants with Fair Scores (70-79)
|
2 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 3 years. Number of participants with Poor Scores (Less than 70)
|
6 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 4 years. Number of participants with Excellent Scores (90-100)
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20 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 4 years. Number of participants with Good Scores (80-89)
|
7 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 4 years. Number of participants with Fair Scores (70-79)
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1 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 4 years. Number of participants with Poor Scores (Less than 70)
|
3 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 5 years. Number of participants with Excellent Scores (90-100)
|
85 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 5 years. Number of participants with Good Scores (80-89)
|
11 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 5 years. Number of participants with Fair Scores (70-79)
|
8 Participant hips
|
|
Annual Total Harris Hip Score
Harris Hip score at 5 years. Number of participants with Poor Scores (Less than 70)
|
5 Participant hips
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SECONDARY outcome
Timeframe: Annually through 5 yearsPopulation: All study participants who attended their annual clinical evaluation
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent This Secondary Outcome reports on the Pain Sub Score which has categories of None (44 points), Slight (40), Mild (30), Moderate (20), Marked (10), and Totally Disabled (0)
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=128 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "None" Score (44)
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84 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "Slight" Score (40)
|
28 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "Mild" Score (30)
|
7 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "Moderate" Score (20)
|
6 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "Marked" Score (10)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 1 year Participants with a "Totally Disabled" Score (0)
|
1 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "None" Score (44)
|
87 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "Slight" Score (40)
|
18 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "Mild" Score (30)
|
11 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "Moderate" Score (20)
|
5 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "Marked" Score (10)
|
1 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 2 years Participants with a "Totally Disabled" Score (0)
|
1 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "None" Score (44)
|
51 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "Slight" Score (40)
|
8 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "Mild" Score (30)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "Moderate" Score (20)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "Marked" Score (10)
|
1 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 3 years Participants with a "Totally Disabled" Score (0)
|
0 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "None" Score (44)
|
23 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "Slight" Score (40)
|
6 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "Mild" Score (30)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "Moderate" Score (20)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "Marked" Score (10)
|
2 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 4 years Participants with a "Totally Disabled" Score (0)
|
0 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "None" Score (44)
|
81 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "Slight" Score (40)
|
15 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "Mild" Score (30)
|
7 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "Moderate" Score (20)
|
7 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "Marked" Score (10)
|
0 Participant hips
|
|
Annual Harris Hip Pain Sub Score
Harris Hip Pain Sub Score at 5 years Participants with a "Totally Disabled" Score (0)
|
0 Participant hips
|
SECONDARY outcome
Timeframe: Annually through 5 yearsPopulation: All Study Participants who attended their annual clinical evaluation
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent This Secondary Outcome reports on the Function and Activity Sub Score which has categories of Normal (40-47 points), Mild Dysfunction (30-39), Moderate Dysfunction (20-29), Severe Dysfunction (10-19), and Disabled (0 - 9)
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=128 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 1 Year Subjects with a "Normal" Score (40-47)
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96 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 1 Year Subjects with a "Mild Dysfunction" Score (30-39)
|
28 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 1 Yr Subjects with a "Moderate Dysfunction" Score (20-29)
|
3 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 1 Year Subjects with a "Severe Dysfunction" Score (10-19)
|
1 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 1 Year Subjects with a "Disabled" Score (0-9)
|
0 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 2 Years Subjects with a "Normal" Score (40-47)
|
99 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 2 Years Subjects with a "Mild Dysfunction" Score (30-39)
|
16 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 2 Yrs Subjects with a "Moderate Dysfunction" Score (20-29)
|
7 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 2 Years Subjects with a "Severe Dysfunction" Score (10-19)
|
1 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 2 Years Subjects with a "Disabled" Score (0-9)
|
0 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 3 Years Subjects with a "Normal" Score (40-47)
|
51 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 3 Years Subjects with a "Mild Dysfunction" Score (30-39)
|
12 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 3 Yrs Subjects with a "Moderate Dysfunction" Score (20-29)
|
3 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 3 Years Subjects with a "Severe Dysfunction" Score (10-19)
|
1 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 3 Years Subjects with a "Disabled" Score (0-9)
|
0 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 4 Years Subjects with a "Normal" Score (40-47)
|
20 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 4 Years Subjects with a "Mild Dysfunction" Score (30-39)
|
9 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 4 Yrs Subjects with a "Moderate Dysfunction" Score (20-29)
|
5 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 4 Years Subjects with a "Severe Dysfunction" Score (10-19)
|
0 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 4 Years Subjects with a "Disabled" Score (0-9)
|
1 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 5 Years Subjects with a "Normal" Score (40-47)
|
87 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 5 Years Subjects with a "Mild Dysfunction" Score (30-39)
|
14 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 5 Yrs Subjects with a "Moderate Dysfunction" Score (20-29)
|
6 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 5 Years Subjects with a "Severe Dysfunction" Score (10-19)
|
2 Participant Hips
|
|
Annual Harris Hip Function and Activity Score
Harris Hip Function and Activity Score at 5 Years Subjects with a "Disabled" Score (0-9)
|
1 Participant Hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Acetabular cup version is the angle formed between the axis of the implant and the coronal plane of the body. Acetabular version typically ranges between 11.5 and 28.5 degrees.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=107 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Acetabular Cup Version - Annual Measurements
Acetabular cup version degrees, measured at 1 year
|
22.8 Degrees
Standard Deviation 8.73
|
|
Acetabular Cup Version - Annual Measurements
Acetabular cup version degrees, measured at 2 years
|
23.7 Degrees
Standard Deviation 7.51
|
|
Acetabular Cup Version - Annual Measurements
Acetabular cup version degrees, measured at 3 years
|
25.1 Degrees
Standard Deviation 5.56
|
|
Acetabular Cup Version - Annual Measurements
Acetabular cup version degrees, measured at 4 years
|
23.8 Degrees
Standard Deviation 6.42
|
|
Acetabular Cup Version - Annual Measurements
Acetabular cup version degrees, measured at 5 years
|
26.1 Degrees
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Acetabular cup inclination is the angle between the longitudinal axis of the patient and a perpendicular line to the major axis of the cup projection. The target acetabular cup inclination is between 30-50 degrees
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=124 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Acetabular Cup Inclination
Acetabular cup inclination, measured at 1 year
|
42.9 Degrees
Standard Deviation 8.76
|
|
Acetabular Cup Inclination
Acetabular cup inclination, measured at 2 years
|
42.2 Degrees
Standard Deviation 8.19
|
|
Acetabular Cup Inclination
Acetabular cup inclination, measured at 3 years
|
42.6 Degrees
Standard Deviation 7.62
|
|
Acetabular Cup Inclination
Acetabular cup inclination, measured at 4 years
|
43 Degrees
Standard Deviation 8.44
|
|
Acetabular Cup Inclination
Acetabular cup inclination, measured at 5 years
|
43.5 Degrees
Standard Deviation 8.05
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Acetabular migration is the superior migration of the implant within the pelvic bone
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=126 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Acetabular Cup Migration
Number of Participants with acetabular cup migration at 1 year
|
0 Participant Hips
|
|
Acetabular Cup Migration
Number of Participants with acetabular cup migration at 2 years
|
0 Participant Hips
|
|
Acetabular Cup Migration
Number of Participants with acetabular cup migration at 3 years
|
0 Participant Hips
|
|
Acetabular Cup Migration
Number of Participants with acetabular cup migration at 4 years
|
0 Participant Hips
|
|
Acetabular Cup Migration
Number of Participants with acetabular cup migration at 5 years
|
0 Participant Hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Heterotopic ossification is the abnormal formation of bone in soft tissues, such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class 0 being least impactful and Class IV being most impactful
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Class 0
|
87 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Class I
|
15 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Class II
|
21 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Class III
|
3 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Class IV
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess · Unable to assess
|
1 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Class 0
|
78 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Class I
|
17 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Class II
|
25 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Class III
|
4 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Class IV
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess · Unable to assess
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Class 0
|
32 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Class I
|
10 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Class II
|
22 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Class III
|
2 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Class IV
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess · Unable to assess
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Class 0
|
21 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Class I
|
5 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Class II
|
7 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Class III
|
2 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Class IV
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess · Unable to assess
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Class 0
|
64 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Class I
|
16 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Class II
|
26 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Class III
|
3 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Class IV
|
0 Participant Hips
|
|
Heterotopic Ossification
Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess · Unable to assess
|
0 Participant Hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Radiolucent lines are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack on bone ingrowth or possible loosening of the implant. Radiolucent lines greater than 1mm wide were considered reportable for this study.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Acetabular Radiolucent Lines
Number of study Participants with radiolucent lines greater than 1mm in width at 1 year
|
1 Participant hips
|
|
Acetabular Radiolucent Lines
Number of study Participants with radiolucent lines greater than 1mm in width at 2 years
|
1 Participant hips
|
|
Acetabular Radiolucent Lines
Number of study Participants with radiolucent lines greater than 1mm in width at 3 years
|
1 Participant hips
|
|
Acetabular Radiolucent Lines
Number of study Participants with radiolucent lines greater than 1mm in width at 4 years
|
1 Participant hips
|
|
Acetabular Radiolucent Lines
Number of study Participants with radiolucent lines greater than 1mm in width at 5 years
|
1 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Acetabular Osteolysis
Number of study Participants with acetabular osteolysis at 1 year
|
2 Participant hips
|
|
Acetabular Osteolysis
Number of study Participants with acetabular osteolysis at 2 years
|
2 Participant hips
|
|
Acetabular Osteolysis
Number of study Participants with acetabular osteolysis at 3 years
|
0 Participant hips
|
|
Acetabular Osteolysis
Number of study Participants with acetabular osteolysis at 4 years
|
0 Participant hips
|
|
Acetabular Osteolysis
Number of study Participants with acetabular osteolysis at 5 years
|
1 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 though 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Acetabular Sclerotic Lines
Number of study Participants with acetabular sclerotic lines present at 1 Year
|
1 Participant Hips
|
|
Acetabular Sclerotic Lines
Number of study Participants with acetabular sclerotic lines present at 2 Years
|
3 Participant Hips
|
|
Acetabular Sclerotic Lines
Number of study Participants with acetabular sclerotic lines present at 3 Years
|
3 Participant Hips
|
|
Acetabular Sclerotic Lines
Number of study Participants with acetabular sclerotic lines present at 4 Years
|
3 Participant Hips
|
|
Acetabular Sclerotic Lines
Number of study Participants with acetabular sclerotic lines present at 5 Years
|
3 Participant Hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Femoral stem position is categorized as neutral, valgus, or varus. A neutral stem is centered within the femoral canal that runs through the center of the femur's long axis. A valgus femoral stem is positioned slightly towards the medial side of the femoral canal, and a varus femoral stem is positioned slightly towards the lateral side of the femoral canal.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Position
Femoral stem position in study patients at 1 year follow-up · Number with Neutral stem position
|
79 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 1 year follow-up · Number with Valgus stem position
|
10 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 1 year follow-up · Number with Varus stem position
|
35 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 1 year follow-up · Unable to assess
|
2 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 1 year follow-up · Indeterminate
|
1 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 2 year follow-up · Number with Neutral stem position
|
77 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 2 year follow-up · Number with Valgus stem position
|
9 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 2 year follow-up · Number with Varus stem position
|
38 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 2 year follow-up · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 2 year follow-up · Indeterminate
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 3 year follow-up · Number with Neutral stem position
|
35 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 3 year follow-up · Number with Valgus stem position
|
6 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 3 year follow-up · Number with Varus stem position
|
24 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 3 year follow-up · Unable to assess
|
1 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 3 year follow-up · Indeterminate
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 4 year follow-up · Number with Neutral stem position
|
19 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 4 year follow-up · Number with Valgus stem position
|
4 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 4 year follow-up · Number with Varus stem position
|
12 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 4 year follow-up · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 4 year follow-up · Indeterminate
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 5 year follow-up · Number with Neutral stem position
|
67 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 5 year follow-up · Number with Valgus stem position
|
8 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 5 year follow-up · Number with Varus stem position
|
34 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 5 year follow-up · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Position
Femoral stem position in study patients at 5 year follow-up · Indeterminate
|
0 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Femoral stem tilt is a measurement taken at each post-operative year and compared against baseline images collected at 6-weeks post-operative. The measurement captures changes in the position of the femoral stem over time. Tilt greater than 2 degrees was considered reportable for this study
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Tilt
Number of Study Participants with femoral tilt greater than 2 degrees at 1 year
|
3 Participant hips
|
|
Femoral Stem Tilt
Number of Study Participants with femoral tilt greater than 2 degrees at 2 years
|
3 Participant hips
|
|
Femoral Stem Tilt
Number of Study Participants with femoral tilt greater than 2 degrees at 3 years
|
3 Participant hips
|
|
Femoral Stem Tilt
Number of Study Participants with femoral tilt greater than 2 degrees at 4 years
|
2 Participant hips
|
|
Femoral Stem Tilt
Number of Study Participants with femoral tilt greater than 2 degrees at 5 years
|
5 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Subsidence
Number of study Participants with femoral stem subsidence greater that 2mm at 1 year
|
0 Participant hips
|
|
Femoral Stem Subsidence
Number of study Participants with femoral stem subsidence greater that 2mm at 2 years
|
0 Participant hips
|
|
Femoral Stem Subsidence
Number of study Participants with femoral stem subsidence greater that 2mm at 3 years
|
0 Participant hips
|
|
Femoral Stem Subsidence
Number of study Participants with femoral stem subsidence greater that 2mm at 4 years
|
0 Participant hips
|
|
Femoral Stem Subsidence
Number of study Participants with femoral stem subsidence greater that 2mm at 5 years
|
0 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Heterotopic ossification is the abnormal formation of bone in soft tissues such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class O having no bone growth in soft tissue, Class I being least impactful and Class IV being most impactful.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Class 0
|
87 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Class I
|
21 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Class II
|
14 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Class III
|
3 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Class IV
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 1 year · Unable to assess
|
2 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Class 0
|
80 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Class I
|
21 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Class II
|
17 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Class III
|
6 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Class IV
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 2 years · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Class 0
|
40 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Class I
|
13 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Class II
|
10 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Class III
|
3 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Class IV
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 3 years · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Class 0
|
21 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Class I
|
8 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Class II
|
3 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Class III
|
3 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Class IV
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 4 years · Unable to assess
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Class 0
|
65 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Class I
|
21 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Class II
|
19 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Class III
|
4 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Class IV
|
0 Participant hips
|
|
Femoral Stem Heterotopic Ossification
Study Participant Femoral Heterotopic Ossification at 5 years · Unable to assess
|
0 Participant hips
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Radiolucencies are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack of bone ingrowth into the implant or possible loosening of the implant
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Radiolucent Lines
Study Participants with femoral radiolucent lines present at 1 year
|
0 Participants
|
|
Femoral Radiolucent Lines
Study Participants with femoral radiolucent lines present at 2 years
|
1 Participants
|
|
Femoral Radiolucent Lines
Study Participants with femoral radiolucent lines present at 3 years
|
0 Participants
|
|
Femoral Radiolucent Lines
Study Participants with femoral radiolucent lines present at 4 years
|
0 Participants
|
|
Femoral Radiolucent Lines
Study Participants with femoral radiolucent lines present at 5 years
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Osteolysis
Number of study Participants with femoral osteolysis at 1 year
|
0 Participants
|
|
Femoral Osteolysis
Number of study Participants with femoral osteolysis at 2 years
|
0 Participants
|
|
Femoral Osteolysis
Number of study Participants with femoral osteolysis at 3 years
|
0 Participants
|
|
Femoral Osteolysis
Number of study Participants with femoral osteolysis at 4 years
|
0 Participants
|
|
Femoral Osteolysis
Number of study Participants with femoral osteolysis at 5 years
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Sclerotic Lines
Number of study participants with femoral sclerotic lines present at 1 year
|
1 Participants
|
|
Femoral Stem Sclerotic Lines
Number of study participants with femoral sclerotic lines present at 2 years
|
5 Participants
|
|
Femoral Stem Sclerotic Lines
Number of study participants with femoral sclerotic lines present at 3 years
|
5 Participants
|
|
Femoral Stem Sclerotic Lines
Number of study participants with femoral sclerotic lines present at 4 years
|
1 Participants
|
|
Femoral Stem Sclerotic Lines
Number of study participants with femoral sclerotic lines present at 5 years
|
7 Participants
|
SECONDARY outcome
Timeframe: Measure from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant Hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Femoral Stem Calcar Resorption
Study patients with calcar resorption indicated on x-rays at 1 year
|
1 Participants
|
|
Femoral Stem Calcar Resorption
Study patients with calcar resorption indicated on x-rays at 2 years
|
2 Participants
|
|
Femoral Stem Calcar Resorption
Study patients with calcar resorption indicated on x-rays at 3 years
|
2 Participants
|
|
Femoral Stem Calcar Resorption
Study patients with calcar resorption indicated on x-rays at 4 years
|
2 Participants
|
|
Femoral Stem Calcar Resorption
Study patients with calcar resorption indicated on x-rays at 5 years
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured from x-rays taken annually, years 1 through 5Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
Near the top of the femur is a region of bone called the calcar femorale that provides strength to the femur when compressive forces are applied. During preparation of the femur to receive the femoral implant there is the possibility of fractures occurring in this region
Outcome measures
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=127 Participant hips
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Femoral Stem Calcar Fracture
Number of Study participants with a calcar fracture noted on x-rays at 1 year
|
0 Participants
|
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Femoral Stem Calcar Fracture
Number of Study participants with a calcar fracture noted on x-rays at 2 years
|
0 Participants
|
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Femoral Stem Calcar Fracture
Number of Study participants with a calcar fracture noted on x-rays at 3 years
|
0 Participants
|
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Femoral Stem Calcar Fracture
Number of Study participants with a calcar fracture noted on x-rays at 4 years
|
0 Participants
|
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Femoral Stem Calcar Fracture
Number of Study participants with a calcar fracture noted on x-rays at 5 years
|
0 Participants
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Adverse Events
CERAMAX COC 36mm Acetabular Cup
Serious events: 86 serious events
Other events: 141 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=170 participants at risk
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
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|---|---|
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Cardiac disorders
Acute myocardial infarction
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Cardiac disorders
Atrial fibrillation
|
0.59%
1/170 • Number of events 4 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Cardiac disorders
Atrial flutter
|
0.59%
1/170 • Number of events 4 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Cardiac disorders
Foetal heart rate deceleration abnormality
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Anal stenosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Dysphagia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
Nausea
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Gastrointestinal disorders
vomiting
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
General disorders
Chest pain
|
1.2%
2/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Arthritis infective
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Bacteraemia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Cellulitis
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Clostridium difficile infection
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Empyema
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Haematoma infection
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Herpes zoster
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Medical device site joint infection
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Metapneumovirus infection
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Pneumonia
|
2.9%
5/170 • Number of events 5 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Sepsis
|
1.2%
2/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Sinusitis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Infections and infestations
Upper respiratory tract infection
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Fall
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.8%
3/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Joint effusion
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Joint instability
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
1.8%
3/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Seroma
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wound
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.2%
2/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
22.9%
39/170 • Number of events 39 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.1%
7/170 • Number of events 7 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Synovial disorder
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Alcoholic seizure
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Cerebrovascular accident
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Nervous system disorder
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.59%
1/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Product Issues
Device failure
|
1.2%
2/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Product Issues
Device loosening
|
1.8%
3/170 • Number of events 3 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Psychiatric disorders
Delirium tremens
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Psychiatric disorders
Homicidal ideation
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
2/170 • Number of events 11 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Reproductive system and breast disorders
Cystocele
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Reproductive system and breast disorders
Rectocele
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/170 • Number of events 2 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Vascular disorders
Aortic stenosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Vascular disorders
Deep vein thrombosis
|
0.59%
1/170 • Number of events 1 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
Other adverse events
| Measure |
CERAMAX COC 36mm Acetabular Cup
n=170 participants at risk
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
21.8%
37/170 • Number of events 52 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
21.8%
37/170 • Number of events 48 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
17.6%
30/170 • Number of events 35 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
28/170 • Number of events 29 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.8%
20/170 • Number of events 24 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Injury, poisoning and procedural complications
Fall
|
11.2%
19/170 • Number of events 23 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
8.8%
15/170 • Number of events 20 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
10/170 • Number of events 10 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.7%
8/170 • Number of events 11 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.7%
8/170 • Number of events 8 • Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60