Trial Outcomes & Findings for PFC Sigma Fixed and Mobile Knee Study (NCT NCT00208325)

NCT ID: NCT00208325

Last Updated: 2016-09-13

Results Overview

Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

754 participants

Primary outcome timeframe

1 year

Results posted on

2016-09-13

Participant Flow

754 subjects were consented into the study, however only 720 received study treatment.

Participant milestones

Participant milestones
Measure	PFC Fixed Bearing PCL Sacrificed Fixed bearing P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement	PFC Mobile Bearing PCL Sacrificed Mobile bearing P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement	PFC Fixed Bearing PCL Retained Fixed bearing P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement	PFC Mobile Bearing PCL Retained Mobile bearing P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement
Overall Study STARTED	193	196	170	161
Overall Study COMPLETED	142	142	156	147
Overall Study NOT COMPLETED	51	54	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	PFC Fixed Bearing PCL Sacrificed Fixed bearing P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement	PFC Mobile Bearing PCL Sacrificed Mobile bearing P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement	PFC Fixed Bearing PCL Retained Fixed bearing P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement	PFC Mobile Bearing PCL Retained Mobile bearing P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement
Overall Study Death	18	19	7	5
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Revision	4	1	0	4
Overall Study Lost to Follow-up	1	0	2	0
Overall Study Unsurfaced to Resurfaced Patella	4	4	1	3
Overall Study Does not wish to Continue in Study	5	8	3	2
Overall Study Other	2	1	1	0
Overall Study Mis-Randomized	17	20	0	0

Baseline Characteristics

PFC Sigma Fixed and Mobile Knee Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement	PFC Sigma Fixed Bearing PCL Retained n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Retained P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Retained n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Retained P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement	Total n=683 Participants Total of all reporting groups
Age, Continuous	69.8 years STANDARD_DEVIATION 8.16 • n=5 Participants	70.2 years STANDARD_DEVIATION 7.60 • n=7 Participants	70.1 years STANDARD_DEVIATION 7.88 • n=5 Participants	69.2 years STANDARD_DEVIATION 8.59 • n=4 Participants	69.8 years STANDARD_DEVIATION 8.06 • n=21 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	96 Participants n=7 Participants	102 Participants n=5 Participants	87 Participants n=4 Participants	379 Participants n=21 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	80 Participants n=7 Participants	68 Participants n=5 Participants	74 Participants n=4 Participants	304 Participants n=21 Participants
Region of Enrollment United Kingdom	176 participants n=5 Participants	176 participants n=7 Participants	170 participants n=5 Participants	161 participants n=4 Participants	683 participants n=21 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=168 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=167 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	108.8 degrees Standard Deviation 13.41	108.4 degrees Standard Deviation 12.54

PRIMARY outcome

Timeframe: 1 year

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=158 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=155 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	100.6 degrees Standard Deviation 12.94	101.6 degrees Standard Deviation 12.24

PRIMARY outcome

Timeframe: Change from pre-op to 1 year

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=164 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=164 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	13.4 degrees Standard Deviation 17.17	12.3 degrees Standard Deviation 18.70

PRIMARY outcome

Timeframe: Change from pre-op to 1 year

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=158 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=153 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	5.8 degrees Standard Deviation 15.83	8.1 degrees Standard Deviation 15.74

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=156 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=148 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	13.9 degrees Standard Deviation 15.81	12.0 degrees Standard Deviation 17.99

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	8.7 degrees Standard Deviation 14.74	10.2 degrees Standard Deviation 15.72

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=123 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=124 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	15.2 degrees Standard Deviation 15.46	14.5 degrees Standard Deviation 18.77

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=145 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=138 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	-19.1 units on a scale Standard Deviation 8.35	-17.6 units on a scale Standard Deviation 9.92

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=134 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=118 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	-18.8 units on a scale Standard Deviation 9.93	-18.1 units on a scale Standard Deviation 8.90

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=114 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=111 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	-20.4 units on a scale Standard Deviation 10.33	-19.9 units on a scale Standard Deviation 8.95

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=154 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=143 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	57.2 units on a scale Standard Deviation 18.66	56.8 units on a scale Standard Deviation 18.09

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=152 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=143 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	50.7 units on a scale Standard Deviation 21.02	49.5 units on a scale Standard Deviation 24.67

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=122 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=120 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	57.9 units on a scale Standard Deviation 19.42	55.6 units on a scale Standard Deviation 20.36

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=155 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=144 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	23.8 units on a scale Standard Deviation 22.18	26.1 units on a scale Standard Deviation 21.47

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=154 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=146 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	25.0 units on a scale Standard Deviation 22.51	23.6 units on a scale Standard Deviation 19.62

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=124 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=125 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	20.3 units on a scale Standard Deviation 24.54	20.5 units on a scale Standard Deviation 22.06

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	73 percentage of participants	67 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	76 percentage of participants	76 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	61 percentage of participants	53 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	88 percentage of participants	85 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	81 percentage of participants	82 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	65 percentage of participants	68 percentage of participants

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=130 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=118 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	12.38 units on a scale Standard Deviation 11.23	10.96 units on a scale Standard Deviation 11.97

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=139 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=130 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	10.47 units on a scale Standard Deviation 10.76	9.68 units on a scale Standard Deviation 11.38

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=107 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=109 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	10.90 units on a scale Standard Deviation 11.84	8.75 units on a scale Standard Deviation 12.47

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=130 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=118 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	0.67 units on a scale Standard Deviation 10.71	1.91 units on a scale Standard Deviation 10.27

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=139 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=130 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	1.86 units on a scale Standard Deviation 12.69	0.26 units on a scale Standard Deviation 11.86

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=107 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=109 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	1.51 units on a scale Standard Deviation 12.74	1.98 units on a scale Standard Deviation 10.64

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=152 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=141 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	9.6 units on a scale Standard Deviation 6.89	8.4 units on a scale Standard Deviation 7.40

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=153 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=144 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	10.6 units on a scale Standard Deviation 7.14	9.7 units on a scale Standard Deviation 7.35

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=122 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=122 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	10.0 units on a scale Standard Deviation 7.04	8.6 units on a scale Standard Deviation 8.07

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	9 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	9 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	8 percentage of participants	6 percentage of participants

SECONDARY outcome

Timeframe: Operative

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	10 percentage of participants	10 percentage of participants

SECONDARY outcome

Timeframe: Operative

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	7 percentage of participants	7 percentage of participants

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	98.9 percentage of participants Interval 95.5 to 99.7	98.3 percentage of participants Interval 94.7 to 99.4

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=170 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=161 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	99.4 percentage of participants Interval 95.9 to 99.9	98.1 percentage of participants Interval 94.3 to 99.4

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=176 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=176 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	96.3 percentage of participants Interval 92.0 to 98.3	97.6 percentage of participants Interval 93.7 to 99.1

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=89 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	75 percentage of participants	69 percentage of participants

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=87 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	72 percentage of participants	66 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=89 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	65 percentage of participants	54 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=87 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	57 percentage of participants	53 percentage of participants

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=89 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	88 percentage of participants	83 percentage of participants

SECONDARY outcome

Timeframe: 2 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=87 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	88 percentage of participants	86 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=89 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	65 percentage of participants	71 percentage of participants

SECONDARY outcome

Timeframe: 5 Years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=88 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=87 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	66 percentage of participants	64 percentage of participants

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=75 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=71 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	8.8 units on a scale Standard Deviation 7.03	9.4 units on a scale Standard Deviation 6.37

SECONDARY outcome

Timeframe: Change from pre-op to 2 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=77 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=70 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	10.3 units on a scale Standard Deviation 6.72	7.5 units on a scale Standard Deviation 8.25

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=60 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=62 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	8.9 units on a scale Standard Deviation 7.35	9.1 units on a scale Standard Deviation 7.16

SECONDARY outcome

Timeframe: Change from pre-op to 5 years

Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.

Outcome measures

Outcome measures
Measure	PFC Fixed Bearing PCL Sacrificed n=62 Participants PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=60 Participants PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	11.2 units on a scale Standard Deviation 6.57	8.1 units on a scale Standard Deviation 8.94

Adverse Events

PFC Fixed Bearing PCL Sacrificed

Serious events: 111 serious events

Other events: 0 other events

Deaths: 0 deaths

PFC Sigma RP PCL Sacrificed

Serious events: 107 serious events

Other events: 0 other events

Deaths: 0 deaths

PFC Sigma Fixed Bearing PCL Retained

Serious events: 110 serious events

Other events: 0 other events

Deaths: 0 deaths

PFC Sigma RP PCL Retained

Serious events: 96 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PFC Fixed Bearing PCL Sacrificed n=193 participants at risk PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Sacrificed n=196 participants at risk PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement	PFC Sigma Fixed Bearing PCL Retained n=170 participants at risk PFC Sigma Fixed Bearing Total Knee System with PCL Retained P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement	PFC Sigma RP PCL Retained n=161 participants at risk PFC Sigma Rotating Platform Total Knee System with PCL Retained P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 4/193	2.0% 4/196	0.00% 0/170	1.9% 3/161
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 3/193	1.5% 3/196	0.59% 1/170	1.2% 2/161
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Respiratory, thoracic and mediastinal disorders Throat pain	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Blood and lymphatic system disorders Anaemia	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Blood and lymphatic system disorders Lymphocytosis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Cardiac disorders Angina pectoris	1.0% 2/193	2.0% 4/196	1.2% 2/170	0.62% 1/161
Cardiac disorders Arrhythmia	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Cardiac disorders Atrial fibrillation	1.6% 3/193	1.0% 2/196	1.2% 2/170	2.5% 4/161
Cardiac disorders Atrial flutter	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Cardiac disorders Atrioventricular block	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Cardiac disorders Atrioventricular block complete	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Cardiac disorders Cardiac arrest	0.00% 0/193	1.0% 2/196	0.59% 1/170	0.00% 0/161
Cardiac disorders Cardiac failure	0.52% 1/193	1.5% 3/196	0.00% 0/170	0.62% 1/161
Cardiac disorders Cardiac disorders NEC	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Cardiac disorders Cardiovascular disorder	0.52% 1/193	1.0% 2/196	0.59% 1/170	0.62% 1/161
Cardiac disorders Coronary artery disease	0.00% 0/193	1.0% 2/196	0.59% 1/170	2.5% 4/161
Cardiac disorders Heart enlarged	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Cardiac disorders Mitral valve incompetence	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Cardiac disorders Myocardial infarction	1.0% 2/193	2.0% 4/196	1.2% 2/170	0.00% 0/161
Ear and labyrinth disorders Tinnitus	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Eye disorders Blindness	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Eye disorders Cataract	1.0% 2/193	0.00% 0/196	5.9% 10/170	2.5% 4/161
Eye disorders Eye haemorrhage	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Eye disorders Diplopia	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Eye disorders Glaucoma	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Eye disorders Macular degeneration	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Eye disorders Macular hole	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Eye disorders Uveitis	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Eye disorders Visual acuity reduced	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Abdominal discomfort	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Gastrointestinal disorders Abdominal mass	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Abdominal pain	1.0% 2/193	1.0% 2/196	1.2% 2/170	1.2% 2/161
Gastrointestinal disorders Abdominal pain upper	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Anal haemorrhage	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Gastrointestinal disorders Diarrhoea	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Gastrointestinal disorders Ascites	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Dyspepsia	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Constipation	0.00% 0/193	0.00% 0/196	0.59% 1/170	1.2% 2/161
Gastrointestinal disorders Faeces discoloured	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Faecal incontinence	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Faeces pale	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Frequent bowel movements	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Hiatal hernia	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Gastric ulcer	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Hiatus hernia	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Haematemesis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Inguinal hernia	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Intestinal perforation	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Obstruction gastric	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Oral pain	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Gastrointestinal disorders Pancreatitis acute	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Gastrointestinal disorders Rectal haemorrhage	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Gastrointestinal disorders Umbilical hernia	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
General disorders Chest pain	1.6% 3/193	1.5% 3/196	0.00% 0/170	0.00% 0/161
General disorders Death- Unknown	8.3% 16/193	5.6% 11/196	1.8% 3/170	1.9% 3/161
General disorders Device connection issue	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
General disorders Device dislocation	0.00% 0/193	1.0% 2/196	0.59% 1/170	0.00% 0/161
General disorders Device extrusion	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
General disorders Gait disturbance	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
General disorders Malaise	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
General disorders Medical device complication	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
General disorders Pain	2.1% 4/193	0.51% 1/196	0.59% 1/170	1.2% 2/161
General disorders Spinal pain	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
General disorders Weight bearing difficulty	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
General disorders Chest discomfort	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
General disorders Device component issue	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
General disorders Device failure	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
General disorders Hernia	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
General disorders Oedema peripheral	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
General disorders Pain and discomfort NEC	0.00% 0/193	0.00% 0/196	1.8% 3/170	0.00% 0/161
General disorders Pyrexia	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
General disorders Surgical failure	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
General disorders Swelling	0.00% 0/193	0.00% 0/196	1.8% 3/170	0.62% 1/161
Hepatobiliary disorders Cholelithiasis	1.6% 3/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Hepatobiliary disorders Biliary colic	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Hepatobiliary disorders Cholecystitis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Hepatobiliary disorders Cholecystitis chronic	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Hepatobiliary disorders Gallbladder perforation	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Hepatobiliary disorders Jaundice	0.00% 0/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Infections and infestations Cellulitis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Infections and infestations Diverticulitis	1.0% 2/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Infections and infestations Helicobacter gastritis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Infections and infestations Implant site infection	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Infections and infestations Infection	0.52% 1/193	1.0% 2/196	1.2% 2/170	0.62% 1/161
Infections and infestations Lower respiratory tract infection	0.52% 1/193	0.51% 1/196	0.59% 1/170	1.2% 2/161
Infections and infestations Peritonitis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Infections and infestations Pneumonia	0.00% 0/193	1.5% 3/196	0.59% 1/170	1.2% 2/161
Infections and infestations Post procedural infection	0.52% 1/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Infections and infestations Postoperative wound infection	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Infections and infestations Sepsis	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Infections and infestations Staphylococcal infection	1.6% 3/193	1.0% 2/196	0.00% 0/170	1.9% 3/161
Infections and infestations Stitch abscess	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Infections and infestations Streptococcal infection	0.52% 1/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Infections and infestations Tuberculosis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Infections and infestations Urinary tract infection	0.52% 1/193	0.00% 0/196	0.59% 1/170	1.2% 2/161
Infections and infestations Wound infection	1.0% 2/193	1.0% 2/196	0.59% 1/170	1.2% 2/161
Infections and infestations Wound infection staphylococcal	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Infections and infestations Clostridium difficile colitis	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Infections and infestations Clostridium difficile infection	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Infections and infestations Ear infection staphylococcal	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Infections and infestations Gastroenteritis	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Infections and infestations Helicobacter infection	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Infections and infestations Infected dermal cyst	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Infections and infestations Lobar pneumonia	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Infections and infestations Lower respiratory tract infections NEC	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Infections and infestations Osteomyelitis	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Infections and infestations Pneumonia legionella	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Concussion	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Ear injury	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Fall	2.6% 5/193	4.1% 8/196	2.4% 4/170	4.3% 7/161
Injury, poisoning and procedural complications Femoral neck fracture	1.6% 3/193	0.00% 0/196	2.4% 4/170	0.62% 1/161
Injury, poisoning and procedural complications Femur fracture	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.62% 1/161
Injury, poisoning and procedural complications Glaucoma traumatic	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Head injury	1.0% 2/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Hip fracture	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Humerus fracture	0.52% 1/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Joint dislocation	1.0% 2/193	1.5% 3/196	1.8% 3/170	0.62% 1/161
Injury, poisoning and procedural complications Joint dislocation postoperative	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Joint injury	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.62% 1/161
Injury, poisoning and procedural complications Laceration	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.62% 1/161
Injury, poisoning and procedural complications Limb injury	0.52% 1/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Overdose	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Radius fracture	0.52% 1/193	0.00% 0/196	1.8% 3/170	0.62% 1/161
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Tibia fracture	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Wound complication	1.0% 2/193	1.0% 2/196	0.00% 0/170	1.2% 2/161
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Injury, poisoning and procedural complications Wound secretion	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Injury, poisoning and procedural complications Back injury	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Fractured olecranon	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Hand fracture	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Post procedural complication	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Road traffic accident	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Skin wound	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Upper limb fracture	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Investigations Bone scan	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Investigations Endoscopy	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Investigations Gastrointestinal examination	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Investigations Haemoglobin decreased	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Investigations Prostatic specific antigen increased	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Investigations Staphylococcus test positive	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Investigations Weight decreased	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Investigations Chest X-ray abnormal	0.00% 0/193	0.00% 0/196	0.00% 0/170	1.2% 2/161
Investigations Computerised tomogram abnormal	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Investigations Investigation	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Investigations Liver function test abnormal	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Investigations Macular reflex abnormal	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Investigations Weight loss	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Metabolism and nutrition disorders Decreased appetite	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Metabolism and nutrition disorders Dehydration	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Metabolism and nutrition disorders Diabetes mellitus	1.0% 2/193	0.00% 0/196	0.59% 1/170	1.2% 2/161
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.52% 1/193	1.0% 2/196	0.00% 0/170	1.2% 2/161
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 6/193	3.6% 7/196	4.7% 8/170	6.2% 10/161
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Back pain	1.6% 3/193	0.51% 1/196	0.59% 1/170	1.9% 3/161
Musculoskeletal and connective tissue disorders Foot deformity	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Joint crepitation	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.52% 1/193	0.00% 0/196	2.4% 4/170	1.2% 2/161
Musculoskeletal and connective tissue disorders Joint swelling	1.0% 2/193	2.0% 4/196	0.59% 1/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Mobility decreased	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.52% 1/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Osteoarthritis	14.0% 27/193	14.3% 28/196	21.2% 36/170	14.3% 23/161
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Pain groin	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 2/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/193	1.0% 2/196	0.59% 1/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Stiff knees	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Musculoskeletal and connective tissue disorders Arthritis	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Haemarthrosis	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Joint contracture	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Joint instability	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Joint lock	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Low back pain	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Muscular weakness	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Musculoskeletal deformity	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.6% 3/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Osteosclerosis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Pain in elbow	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Pain in hand	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Musculoskeletal and connective tissue disorders Toe osteoarthritis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Ataxia	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Nervous system disorders Carpal tunnel syndrome	1.0% 2/193	0.00% 0/196	2.4% 4/170	1.2% 2/161
Nervous system disorders Cerebral haemorrhage	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Nervous system disorders Cerebral infarction	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Nervous system disorders Cerebrovascular accident	2.6% 5/193	1.0% 2/196	1.2% 2/170	2.5% 4/161
Nervous system disorders Convulsion	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Nervous system disorders Dementia	1.0% 2/193	1.0% 2/196	0.59% 1/170	0.62% 1/161
Nervous system disorders Dementia Alzheimer's type	0.52% 1/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Nervous system disorders Headache	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Nervous system disorders Hemiparesis	0.52% 1/193	0.51% 1/196	0.59% 1/170	0.62% 1/161
Nervous system disorders Radial nerve palsy	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Nervous system disorders Sciatica	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Nervous system disorders Sensory loss	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Nervous system disorders Syncope	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Nervous system disorders Tethered cord syndrome	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Nervous system disorders Transient ischaemic attack	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.62% 1/161
Nervous system disorders Brain hypoxia	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Burning sensation	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Carotid artery stenosis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Dizziness	1.0% 2/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Dysgraphia	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Hydrocephalus	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Loss of consciousness	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Paraesthesia	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Parkinson's disease	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Nervous system disorders Sensory disturbance	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Psychiatric disorders Anxiety	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Psychiatric disorders Confusional state	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Psychiatric disorders Depression	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Psychiatric disorders Hallucination, auditory	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Psychiatric disorders Agitation	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Psychiatric disorders Completed suicide	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Haematuria	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.62% 1/161
Renal and urinary disorders Renal failure	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.62% 1/161
Renal and urinary disorders Renal failure acute	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Renal and urinary disorders Renal failure chronic	0.00% 0/193	1.0% 2/196	0.59% 1/170	0.00% 0/161
Renal and urinary disorders Renal mass	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Renal and urinary disorders Chromaturia	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Incontinence	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Micturition urgency	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Nephrolithiasis	0.00% 0/193	1.5% 3/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Urinary retention	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Renal and urinary disorders Urine flow decreased	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Reproductive system and breast disorders Breast mass	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Reproductive system and breast disorders Testicular swelling	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Reproductive system and breast disorders Cystocele	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/193	0.00% 0/196	0.59% 1/170	1.2% 2/161
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Angioplasty	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Ankle arthroplasty	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Cholecystectomy	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Surgical and medical procedures Hip arthroplasty	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Surgical and medical procedures Hospitalisation	1.6% 3/193	2.6% 5/196	1.8% 3/170	3.1% 5/161
Surgical and medical procedures Joint arthroplasty	0.52% 1/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Knee arthroplasty	6.2% 12/193	5.6% 11/196	2.4% 4/170	0.62% 1/161
Surgical and medical procedures Rotator cuff repair	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Shoulder operation	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Surgical and medical procedures Wound drainage	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Surgical and medical procedures Breast lump removal	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Surgical and medical procedures Hysterectomy	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Surgical and medical procedures Leg amputation	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Surgical and medical procedures Surgery	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Vascular disorders Aortic aneurysm	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Vascular disorders Aortic aneurysm rupture	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Vascular disorders Deep vein thrombosis	2.1% 4/193	3.6% 7/196	1.2% 2/170	1.9% 3/161
Vascular disorders Haemorrhage	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Vascular disorders Orthostatic hypotension	0.00% 0/193	0.00% 0/196	0.00% 0/170	1.2% 2/161
Vascular disorders Peripheral artery aneurysm	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Vascular disorders Varicose vein	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Vascular disorders Embolism	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Vascular disorders Haematoma	1.0% 2/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Vascular disorders Peripheral vascular disorder	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Vascular disorders Phlebitis	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Vascular disorders Post thrombotic syndrome	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.52% 1/193	0.51% 1/196	2.4% 4/170	1.2% 2/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.52% 1/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasms	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.52% 1/193	0.51% 1/196	0.59% 1/170	1.9% 3/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung metastases	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.0% 2/193	1.0% 2/196	1.8% 3/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/193	0.51% 1/196	0.59% 1/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	1.0% 2/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic neoplasm	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.52% 1/193	0.51% 1/196	0.59% 1/170	1.2% 2/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic neoplasms malignant	0.00% 0/193	1.0% 2/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain secondaries	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/193	0.00% 0/196	0.00% 0/170	1.2% 2/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/193	0.00% 0/196	1.2% 2/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumor NOS	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/193	0.00% 0/196	0.59% 1/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/193	0.00% 0/196	0.00% 0/170	0.62% 1/161
Cardiac disorders Ischaemic Heart Disease	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
General disorders Cyst	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Injury, poisoning and procedural complications Periorbital contusion	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Cancer	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver Cancer	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/193	0.51% 1/196	0.00% 0/170	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161
Skin and subcutaneous tissue disorders Cold Sweat	0.52% 1/193	0.00% 0/196	0.00% 0/170	0.00% 0/161

Other adverse events

Adverse event data not reported

Additional Information

Kimberly Dwyer, Ph.D, CCRA

DePuy International

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.
Publication restrictions are in place

Restriction type: OTHER