Trial Outcomes & Findings for Safety and Effectiveness Study of the Reflection Ceramic Acetabular System (NCT NCT00663351)
NCT ID: NCT00663351
Last Updated: 2022-10-13
Results Overview
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
456 participants
Primary outcome timeframe
Postoperatively through Year 10
Results posted on
2022-10-13
Participant Flow
There were 456 subjects (535 hips) enrolled initially at the beginning of the study. For the Post-Approval Study period (Year 6 through Year 10), 29 subjects (10 from the IP group, 19 from the control group) were excluded from analysis in the Intent-to-Treat (ITT) population and thus not included in the Participant Flow or Outcome Measures for this period.
Unit of analysis: Hips
Participant milestones
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Initial Study (Year 1 up to Year 6)
STARTED
|
308 372
|
148 163
|
|
Initial Study (Year 1 up to Year 6)
COMPLETED
|
298 364
|
129 144
|
|
Initial Study (Year 1 up to Year 6)
NOT COMPLETED
|
10 8
|
19 19
|
|
Post-Approval Study (Year 6 to Year 10)
STARTED
|
298 364
|
129 144
|
|
Post-Approval Study (Year 6 to Year 10)
COMPLETED
|
186 252
|
58 73
|
|
Post-Approval Study (Year 6 to Year 10)
NOT COMPLETED
|
112 112
|
71 71
|
Reasons for withdrawal
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Initial Study (Year 1 up to Year 6)
Lost to Follow-up
|
10
|
19
|
|
Post-Approval Study (Year 6 to Year 10)
Revision Surgery
|
29
|
10
|
|
Post-Approval Study (Year 6 to Year 10)
Withdrawal by Subject
|
8
|
15
|
|
Post-Approval Study (Year 6 to Year 10)
Death
|
18
|
7
|
|
Post-Approval Study (Year 6 to Year 10)
Lost to Follow-up
|
13
|
7
|
|
Post-Approval Study (Year 6 to Year 10)
Withdrawn for Site Termination
|
44
|
32
|
Baseline Characteristics
Safety and Effectiveness Study of the Reflection Ceramic Acetabular System
Baseline characteristics by cohort
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
n=308 Participants
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
n=148 Participants
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
48.7 Years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
54.1 Years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
50.7 Years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Height
|
173.0 cm
STANDARD_DEVIATION 10.08 • n=5 Participants
|
172.3 cm
STANDARD_DEVIATION 9.83 • n=7 Participants
|
172.7 cm
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Weight
|
86.4 kg
STANDARD_DEVIATION 19.28 • n=5 Participants
|
83.3 kg
STANDARD_DEVIATION 18.78 • n=7 Participants
|
85.3 kg
STANDARD_DEVIATION 19.13 • n=5 Participants
|
|
Body mass index (BMI)
|
28.7 kg/m^2
STANDARD_DEVIATION 5.37 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.14 • n=7 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.30 • n=5 Participants
|
|
Previous surgery on affected hip
Yes
|
73 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Previous surgery on affected hip
No
|
235 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Other joint involvement
Yes
|
216 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Other joint involvement
No
|
92 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Physical activity
None
|
22 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Physical activity
Light
|
225 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Physical activity
Moderate
|
56 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Physical activity
Intense
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperatively through Year 10Population: All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Outcome measures
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
n=364 Hips
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
n=144 Hips
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Requiring Revision · RNIA Cohort
|
12 Hips
|
9 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Requiring Revision · RIA Cohort
|
2 Hips
|
1 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Requiring Revision · RR Cohort
|
0 Hips
|
0 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Requiring Revision · CAC Cohort
|
15 Hips
|
0 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Not Requiring Revision · RNIA Cohort
|
156 Hips
|
118 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Not Requiring Revision · RIA Cohort
|
17 Hips
|
9 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Not Requiring Revision · RR Cohort
|
5 Hips
|
7 Hips
|
|
Survival of Hip Implant Based on Number of Hips Requiring Revision
Hips Not Requiring Revision · CAC Cohort
|
157 Hips
|
0 Hips
|
PRIMARY outcome
Timeframe: Postoperatively through Year 10Population: Analysis is presented by individual hip ID numbers to demonstrate time before a revision was required as well as the corresponding cohorts of each. All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.
The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Outcome measures
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
n=29 Hips
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
n=10 Hips
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 168 (RNIA cohort)
|
0.0 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 239 (RNIA cohort)
|
—
|
0.0 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 318 (RNIA cohort)
|
—
|
0.0 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 221 (RIA cohort)
|
0.0 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 348 (CAC cohort)
|
0.0 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 408 (CAC cohort)
|
0.0 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 448 (CAC cohort)
|
0.0 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 113 (RNIA cohort)
|
0.1 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 247 (RNIA cohort)
|
0.1 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 195 (RNIA cohort)
|
0.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 218 (RIA cohort)
|
0.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 458 (CAC cohort)
|
0.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 370 (CAC cohort)
|
0.4 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 398 (CAC cohort)
|
0.4 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 471 (RNIA cohort)
|
0.7 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 500 (CAC cohort)
|
1.1 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 412 (CAC cohort)
|
1.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 127 (RNIA cohort)
|
1.8 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 175 (RNIA cohort)
|
2.2 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 204 (RNIA cohort)
|
2.5 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 392 (CAC cohort)
|
3.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 306 (RNIA cohort)
|
3.4 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 483 (RNIA cohort)
|
3.9 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 167 (RNIA cohort)
|
4.1 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 451 (CAC cohort)
|
4.2 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 490 (CAC cohort)
|
4.2 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 288 (RR cohort)
|
—
|
4.5 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 37 (RNIA cohort)
|
5.5 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 110 (RNIA cohort)
|
—
|
6.2 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 337 (RNIA cohort)
|
—
|
6.5 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 496 (CAC cohort)
|
6.8 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 114 (RNIA cohort)
|
—
|
6.9 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 308 (RNIA cohort)
|
—
|
7.0 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 36 (RNIA cohort)
|
—
|
7.9 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 103 (RNIA cohort)
|
—
|
7.9 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 390 (CAC cohort)
|
8.3 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 385 (CAC cohort)
|
8.4 survival time in years
|
—
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 42 (RNIA cohort)
|
—
|
8.9 survival time in years
|
|
Survival of Hip Implant Based on Time Until Revision Required
Hip ID 450 (CAC cohort)
|
9.9 survival time in years
|
—
|
PRIMARY outcome
Timeframe: Year 6 through Year 10 postoperativelyPopulation: The number analyzed include all enrolled subjects who responded to the questionnaire at each time point.
A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked "Are you satisfied with hip?" and subjects responded either "yes" or "no".
Outcome measures
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
n=298 Participants
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
n=129 Participants
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Subject Satisfaction Questionnaire
Year 6 - "Are you satisfied with hip?" · Yes
|
107 Participants
|
25 Participants
|
|
Subject Satisfaction Questionnaire
Year 6 - "Are you satisfied with hip?" · No
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction Questionnaire
Year 7 - "Are you satisfied with hip?" · Yes
|
179 Participants
|
47 Participants
|
|
Subject Satisfaction Questionnaire
Year 7 - "Are you satisfied with hip?" · No
|
11 Participants
|
4 Participants
|
|
Subject Satisfaction Questionnaire
Year 8 - "Are you satisfied with hip?" · Yes
|
177 Participants
|
45 Participants
|
|
Subject Satisfaction Questionnaire
Year 8 - "Are you satisfied with hip?" · No
|
17 Participants
|
3 Participants
|
|
Subject Satisfaction Questionnaire
Year 9 - "Are you satisfied with hip?" · Yes
|
189 Participants
|
49 Participants
|
|
Subject Satisfaction Questionnaire
Year 9 - "Are you satisfied with hip?" · No
|
19 Participants
|
1 Participants
|
|
Subject Satisfaction Questionnaire
Year 10 - "Are you satisfied with hip?" · Yes
|
206 Participants
|
56 Participants
|
|
Subject Satisfaction Questionnaire
Year 10 - "Are you satisfied with hip?" · No
|
18 Participants
|
4 Participants
|
Adverse Events
Reflection Ceramic-Ceramic Hip System (IP)
Serious events: 18 serious events
Other events: 0 other events
Deaths: 18 deaths
Reflection FSO V (5 Hole) (Control)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Reflection Ceramic-Ceramic Hip System (IP)
n=308 participants at risk
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
Reflection FSO V (5 Hole) (Control)
n=148 participants at risk
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Complications related to an infection
|
0.32%
1/308 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.00%
0/148 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Injury, poisoning and procedural complications
Injuries sustained during a house fire
|
0.32%
1/308 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.00%
0/148 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
General disorders
Found during a death index search, reason unknown
|
0.97%
3/308 • Number of events 3 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.00%
0/148 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
General disorders
Unknown, not reported by site
|
3.2%
10/308 • Number of events 10 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
2.0%
3/148 • Number of events 3 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.32%
1/308 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.00%
0/148 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.65%
2/308 • Number of events 2 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.00%
0/148 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/308 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.68%
1/148 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/308 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.68%
1/148 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic leukemia
|
0.00%
0/308 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.68%
1/148 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/308 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
0.68%
1/148 • Number of events 1 • AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.
|
Other adverse events
Adverse event data not reported
Additional Information
Rachael Winter, Director, Global Clinical Operations
Smith & Nephew, Inc.
Phone: +44 1482 673475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place