Trial Outcomes & Findings for 36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement (NCT NCT00953719)
NCT ID: NCT00953719
Last Updated: 2019-04-10
Results Overview
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
At final follow-up visit, 24 months or later, up to 72 months
Results posted on
2019-04-10
Participant Flow
Patients were selected for recruitment into the study from the general diagnosis population defined as "primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD)." The investigation was conducted at 5 centers. The same inclusion and exclusion criteria applied to both investigational and control groups.
1 subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the Adverse Event data reported, but the subject was not included in the the number of participants because there are no follow-up data on this subject outside of operative details.
Participant milestones
| Measure |
36 mm Ceramic-on-ceramic
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
74
|
|
Overall Study
COMPLETED
|
150
|
69
|
|
Overall Study
NOT COMPLETED
|
19
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
Baseline characteristics by cohort
| Measure |
36 mm Ceramic-on-ceramic
n=168 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=74 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
56.9 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=93 Participants
|
74 participants
n=4 Participants
|
242 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Total Harris Hip Score
|
95.6 units on a scale
Standard Deviation 8.8
|
94.9 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Subscale Score: Pain
|
41.4 units on a scale
Standard Deviation 6.3
|
41.1 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Subscale Score: Function
|
32.1 units on a scale
Standard Deviation 2.5
|
31.6 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Subscale Score: Activities
|
13.2 units on a scale
Standard Deviation 1.4
|
13.0 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Subscale Score: Deformity
|
4.0 units on a scale
Standard Deviation 0
|
4.0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Subscale Score: Range of Motion
|
4.9 units on a scale
Standard Deviation 0.1
|
4.9 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operativelyPopulation: The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=148 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=69 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Harris Hip Score Longitudinal Analysis
6 week Total Harris Hip Score
|
52.6 units on a scale
Standard Deviation 10.9
|
52.0 units on a scale
Standard Deviation 9.5
|
|
Harris Hip Score Longitudinal Analysis
6 month Total Harris Hip Score
|
93.1 units on a scale
Standard Deviation 10.0
|
93.4 units on a scale
Standard Deviation 9.7
|
|
Harris Hip Score Longitudinal Analysis
12 month Total Harris Hip Score
|
95.5 units on a scale
Standard Deviation 6.5
|
95.2 units on a scale
Standard Deviation 7.6
|
|
Harris Hip Score Longitudinal Analysis
24 month Total Harris Hip Score
|
95.7 units on a scale
Standard Deviation 8.2
|
93.7 units on a scale
Standard Deviation 10.2
|
|
Harris Hip Score Longitudinal Analysis
36 month Total Harris Hip Score
|
96.6 units on a scale
Standard Deviation 6.8
|
97.0 units on a scale
Standard Deviation 4.6
|
|
Harris Hip Score Longitudinal Analysis
48 month Total Harris Hip Score
|
94.6 units on a scale
Standard Deviation 10.1
|
93.5 units on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: At final follow-up visit, 24 months or later, up to 72 monthsPopulation: Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).
A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.
Outcome measures
| Measure |
36 mm Ceramic-on-ceramic
n=147 Participants
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=71 Participants
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Proportion of Composite Successes
|
90.5 percentage of participants
|
90.1 percentage of participants
|
Adverse Events
36 mm Ceramic-on-ceramic
Serious events: 0 serious events
Other events: 134 other events
Deaths: 0 deaths
28 mm Ceramic-on-polyethylene
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
36 mm Ceramic-on-ceramic
n=169 participants at risk
36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
|
28 mm Ceramic-on-polyethylene
n=74 participants at risk
28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intra-operative: 2cm non-displaced fracture of posterior femoral neck
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Intraoperative: Blemish on Ceramic Component
|
0.00%
0/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Intraoperative: Broken Drill Bit
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Cardiac disorders
Intraoperative: Cardiovascular
|
1.2%
2/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Blood and lymphatic system disorders
Intraoperative: Hematological
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Intraoperative: Liner Fracture During Surgery
|
0.59%
1/169 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Postoperatve Systemic: Cancer
|
2.4%
4/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Cardiac disorders
Postoperative Systemic: Cardiovascular
|
8.9%
15/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
8.1%
6/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Nervous system disorders
Postoperative Systemic: Central Nervous System
|
3.6%
6/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
5.4%
4/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Skin and subcutaneous tissue disorders
Postoperative Systemic: Dermatological
|
4.8%
8/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Endocrine disorders
Postoperative Systemic: Endocrine/Metabolic
|
2.4%
4/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
8.1%
6/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Gastrointestinal disorders
Postoperative Systemic: Gastrointestinal
|
4.8%
8/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
8.1%
6/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Renal and urinary disorders
Postoperative Systemic: Genitourinary
|
6.0%
10/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
9.5%
7/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Ear and labyrinth disorders
Postoperative Systemic: HEENT
|
4.2%
7/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
8.1%
6/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Blood and lymphatic system disorders
Postoperative Systemic: Hematological
|
0.00%
0/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
5.4%
4/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Systemic: Musculoskeletal
|
55.4%
93/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
59.5%
44/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Nervous system disorders
Postoperative Systemic: Neurological
|
1.8%
3/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Systemic: Other - Fell
|
3.0%
5/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Systemic: Other - Insect Bite
|
0.00%
0/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Pregnancy, puerperium and perinatal conditions
Postoperative Systemic: Pregnancy - 7 Months Gestation
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Nervous system disorders
Postoperative Systemic: Peripheral Nervous System
|
2.4%
4/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Respiratory, thoracic and mediastinal disorders
Postoperative Systemic: Respiratory System
|
2.4%
4/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
5.4%
4/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Vascular disorders
Postoperative Systemic: Thrombosis/Thrombophlebitis
|
3.0%
5/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Systemic: Wound Problem
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Postoperative Operative Site: Acetabular Component Failure
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Postoperative Operative Site: Acetabular Liner Failure
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Infections and infestations
Postoperative Operative Site: Deep Infection
|
1.2%
2/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Skin and subcutaneous tissue disorders
Postoperative Operative Site: Dermatological
|
1.8%
3/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Dislocation
|
1.2%
2/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
5.4%
4/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Postoperative Operative Site: Femoral Component Loosening
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Fracture - Femoral Insertional Fx
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Vascular disorders
Postoperative Operative Site: Hematoma Requiring Drainage
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Heterotopic Bone Formation
|
1.8%
3/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Muscle Weakness
|
2.4%
4/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Musculoskeletal
|
9.5%
16/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Other - Clicking
|
4.2%
7/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Other - Contusion
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Other - Fell
|
1.8%
3/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Other - Hip Pain
|
1.2%
2/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Other - Hip Snapping
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Iliopsoas Tendinitis
|
3.6%
6/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Other - Squeaking
|
4.8%
8/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Other - Stiffness
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Postoperative Operative Site: Subsidence of Femoral Component
|
0.00%
0/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Other - Vibration
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
General disorders
Postoperative Operative Site: Pain
|
4.8%
8/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
2.7%
2/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Pain - Thigh
|
3.6%
6/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
4.1%
3/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Subluxation
|
0.60%
1/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
0.00%
0/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Musculoskeletal and connective tissue disorders
Postoperative Operative Site: Trochanteric Bursitis
|
10.1%
17/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
5.4%
4/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
|
Injury, poisoning and procedural complications
Postoperative Operative Site: Wound Problem
|
3.6%
6/168 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
1.4%
1/74 • Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.
At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study Note: One (1) subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the AE data reported, but was not included in the number of participants because there are no follow-up data on this subject outside of the operative details
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60