Trial Outcomes & Findings for Safety and Efficacy of the Oxford Cementless Partial Knee System (NCT NCT01473134)

NCT ID: NCT01473134

Last Updated: 2025-08-11

Results Overview

This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval. 1. Absence of osteolysis 2. No migration/subsidence of any femoral or tibial component 3. Absence of fractured component Conversely, a radiographic failure is defined as follows: 1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature. 2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of \> 3 mm as compared to 6 week radiographs. 3. A component fracture

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 320 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-08-11

Participant Flow

ELK1078R - bilateral subject was randomized to Investigational arm and received the Cementless device during the initial surgery. During the contralateral surgery, the cemented keel saw was used therefore, the Control device was implanted. Because this subject was randomized to Investigational and received 1 control knee, the investigational count in the participant flow is off by 1. A row was added with a note for this subject.

Unit of analysis: knees

Participant milestones

Measure	Oxford Cementless Partial Knee Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Overall Study STARTED	207 241	113 137
Overall Study COMPLETED	152 181	78 95
Overall Study NOT COMPLETED	55 60	35 42

Reasons for withdrawal

Measure	Oxford Cementless Partial Knee Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Overall Study Lost to Follow-up	21	13
Overall Study Protocol Violation	32	19
Overall Study Withdrawal by Subject	1	2
Overall Study Death	0	1
Overall Study ELK1078R: bilateral subject randomized to investigational, 2nd knee was cemented.	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Oxford Cementless Partial Knee n=241 knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=137 knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.	Total n=378 knees Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 8.7 • n=207 Participants	66.4 years STANDARD_DEVIATION 8.5 • n=113 Participants	66.04 years STANDARD_DEVIATION 8.61 • n=320 Participants
Sex: Female, Male Female	81 Participants n=207 Participants	54 Participants n=113 Participants	135 Participants n=320 Participants
Sex: Female, Male Male	126 Participants n=207 Participants	59 Participants n=113 Participants	185 Participants n=320 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	207 Participants n=207 Participants	113 Participants n=113 Participants	320 Participants n=320 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The analysis was performed on the per protocol population who had a radiographic assessment at the 2+ year follow up interval. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees).

This is a binary endpoint in which a knee is either a "success" or "failure".

To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.

1. Absence of osteolysis

2. No migration/subsidence of any femoral or tibial component

3. Absence of fractured component

Conversely, a radiographic failure is defined as follows:

1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.

2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.

3. A component fracture

Outcome measures

Measure	Oxford Cementless Partial Knee n=211 knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=115 knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Radiographic Success Successful	198 knees	112 knees
Radiographic Success Failure	13 knees	3 knees

PRIMARY outcome

Timeframe: 2 Years

Population: The analysis was performed on the per protocol population who had an evaluation at the 2+ year follow up interval. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees).

This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful result, a knee must reach the 2 year upper window limit with the device intact and without a component revision/removal or a UADE.

Outcome measures

Measure	Oxford Cementless Partial Knee n=216 knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=122 knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE) Successful	203 knees	119 knees
Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE) Failures	13 knees	3 knees

PRIMARY outcome

Timeframe: 2 Years

Population: The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at the 2+ year follow up interval.

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=204 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=116 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
The Knee Society Assessment Score	95.6 score on a scale Standard Deviation 8.3	95.5 score on a scale Standard Deviation 7.0

PRIMARY outcome

Timeframe: 2 Year

Population: The analysis was performed on the per protocol population who completed the The Knee Society Function Score at the 2+ year follow up interval.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=206 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=121 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
The Knee Society Function Score	89.4 score on a scale Standard Deviation 14.4	89.7 score on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Population: The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=241 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=137 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Knee Society Assessment Score Pre-op	43.2 score on a scale Standard Deviation 11	45 score on a scale Standard Deviation 11
Knee Society Assessment Score 6 Week	86.5 score on a scale Standard Deviation 13.7	87 score on a scale Standard Deviation 12.8
Knee Society Assessment Score 6 Month	93.5 score on a scale Standard Deviation 10.3	94.2 score on a scale Standard Deviation 8.3
Knee Society Assessment Score 1 Year	94.1 score on a scale Standard Deviation 9.5	95 score on a scale Standard Deviation 9.3
Knee Society Assessment Score 2 Year	95.5 score on a scale Standard Deviation 8.5	95.6 score on a scale Standard Deviation 6.9
Knee Society Assessment Score 3 Year	95.2 score on a scale Standard Deviation 8.7	94.4 score on a scale Standard Deviation 9.9
Knee Society Assessment Score 4 Year	95.3 score on a scale Standard Deviation 8.6	94.2 score on a scale Standard Deviation 8.8
Knee Society Assessment Score 5 Year	95 score on a scale Standard Deviation 9.1	94.4 score on a scale Standard Deviation 10.3
Knee Society Assessment Score 6 Year	92.8 score on a scale Standard Deviation 13.3	93.6 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Population: The analysis was performed on the bilateral subjects in the per protocol population who had a Knee Society Assessment Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=84 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=50 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Knee Society Score Assessment for Bilateral Subjects Preop	43.4 score on a scale Standard Deviation 10.7	46.0 score on a scale Standard Deviation 11.7
Knee Society Score Assessment for Bilateral Subjects 6 Week	86.6 score on a scale Standard Deviation 14.5	87.7 score on a scale Standard Deviation 12.5
Knee Society Score Assessment for Bilateral Subjects 6 Month	93.7 score on a scale Standard Deviation 10.9	95.6 score on a scale Standard Deviation 5
Knee Society Score Assessment for Bilateral Subjects 1 Year	94.1 score on a scale Standard Deviation 8.6	95.3 score on a scale Standard Deviation 7.4
Knee Society Score Assessment for Bilateral Subjects 2 Year	95.7 score on a scale Standard Deviation 8.6	95.4 score on a scale Standard Deviation 6.4
Knee Society Score Assessment for Bilateral Subjects 3 Year	96.2 score on a scale Standard Deviation 6.1	92.5 score on a scale Standard Deviation 11.8
Knee Society Score Assessment for Bilateral Subjects 4 Year	96.4 score on a scale Standard Deviation 6	92.9 score on a scale Standard Deviation 7.2
Knee Society Score Assessment for Bilateral Subjects 5 Year	92.8 score on a scale Standard Deviation 13.3	92.8 score on a scale Standard Deviation 10
Knee Society Score Assessment for Bilateral Subjects 6 Year	91.4 score on a scale Standard Deviation 9.9	100 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Population: The analysis was performed on the per protocol population who completed the The Knee Society Assessment Score at each follow-up. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=241 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=137 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Knee Society Function Score at All Timepoints Pre-op	58.1 score on a scale Standard Deviation 16	57.7 score on a scale Standard Deviation 17.7
Knee Society Function Score at All Timepoints 6 Week	65.4 score on a scale Standard Deviation 20.4	70.2 score on a scale Standard Deviation 18.5
Knee Society Function Score at All Timepoints 6 Month	86 score on a scale Standard Deviation 15.3	87.4 score on a scale Standard Deviation 15.2
Knee Society Function Score at All Timepoints 1 Year	87.9 score on a scale Standard Deviation 15.9	88 score on a scale Standard Deviation 15.4
Knee Society Function Score at All Timepoints 2 Year	89.9 score on a scale Standard Deviation 13	89.8 score on a scale Standard Deviation 14
Knee Society Function Score at All Timepoints 3 Year	88.5 score on a scale Standard Deviation 15	88.9 score on a scale Standard Deviation 12.8
Knee Society Function Score at All Timepoints 4 Year	87.1 score on a scale Standard Deviation 17.1	90 score on a scale Standard Deviation 11.1
Knee Society Function Score at All Timepoints 5 Year	86.7 score on a scale Standard Deviation 17.4	85.6 score on a scale Standard Deviation 15.2
Knee Society Function Score at All Timepoints 6 Year	83.2 score on a scale Standard Deviation 19.7	85.7 score on a scale Standard Deviation 17.9

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Population: The analysis was performed on the bilateral subjects in the per protocol population who had a Knee Society Function Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.

Outcome measures

Measure	Oxford Cementless Partial Knee n=84 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=50 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Knee Society Function Score for Bilateral Subjects Pre-op	60.1 score on a scale Standard Deviation 15.8	56.3 score on a scale Standard Deviation 19.3
Knee Society Function Score for Bilateral Subjects 6 Week	65.8 score on a scale Standard Deviation 20.3	72 score on a scale Standard Deviation 15.3
Knee Society Function Score for Bilateral Subjects 6 Month	84.5 score on a scale Standard Deviation 16	88.8 score on a scale Standard Deviation 14.7
Knee Society Function Score for Bilateral Subjects 1 Year	85.3 score on a scale Standard Deviation 16.5	86.8 score on a scale Standard Deviation 16.1
Knee Society Function Score for Bilateral Subjects 2 Year	88.6 score on a scale Standard Deviation 13	92.4 score on a scale Standard Deviation 10.5
Knee Society Function Score for Bilateral Subjects 3 Year	89.3 score on a scale Standard Deviation 14.8	93.3 score on a scale Standard Deviation 8.4
Knee Society Function Score for Bilateral Subjects 4 Year	90.7 score on a scale Standard Deviation 13.2	96.1 score on a scale Standard Deviation 6.1
Knee Society Function Score for Bilateral Subjects 5 Year	90 score on a scale Standard Deviation 10.3	90.8 score on a scale Standard Deviation 13.2
Knee Society Function Score for Bilateral Subjects 6 Year	82.2 score on a scale Standard Deviation 18.6	100 score on a scale Standard Deviation 0
Knee Society Function Score for Bilateral Subjects 7 Year	60 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Population: The analysis was performed on the per protocol population who completed the Oxford Knee Score at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants pre-operatively; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

• 12-item self-report measure containing questions regarding the patient's pain and level of function
• The scoring system ranges from 0-4 on each question with 4 representing maximum function and 0 representing poorest function.
• Using this scale, the lowest, worst score is a 0, and the highest, best score is 48.
• The OKS has 2 subscales:

1. Pain

2. Function The pain component score (OKS-PCS) consists of items 2, 3, 7, 11 and 12, and the functional component score consists of items 1, 4, 5, 6, 8, 9, and 10.

Outcome measures

Measure	Oxford Cementless Partial Knee n=241 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=137 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Oxford Knee Score 5 Year	43.7 score on a scale Standard Deviation 5.9	45.3 score on a scale Standard Deviation 4.9
Oxford Knee Score Pre-op	23.7 score on a scale Standard Deviation 8.1	24.9 score on a scale Standard Deviation 7.6
Oxford Knee Score 6 Week	32.4 score on a scale Standard Deviation 7.8	34.5 score on a scale Standard Deviation 7
Oxford Knee Score 6 Month	41.8 score on a scale Standard Deviation 5.8	42.4 score on a scale Standard Deviation 6.1
Oxford Knee Score 1 Year	42.9 score on a scale Standard Deviation 6.3	43.5 score on a scale Standard Deviation 5.7
Oxford Knee Score 2 Year	44.5 score on a scale Standard Deviation 4.5	44.9 score on a scale Standard Deviation 3.9
Oxford Knee Score 3 Year	44.6 score on a scale Standard Deviation 7.7	44.6 score on a scale Standard Deviation 6.2
Oxford Knee Score 4 Year	44.3 score on a scale Standard Deviation 5.3	45 score on a scale Standard Deviation 5.9
Oxford Knee Score 6 Year	41.3 score on a scale Standard Deviation 8.5	44.1 score on a scale Standard Deviation 7.1
Oxford Knee Score 7 Year	44 score on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Pre-operation (baseline), 6 weeks, 6 months, 1y, 3y, 4y, 5y, 6y, 7y

Population: The analysis was performed on the per protocol population had a radiographic assessment at each follow-up timepoint. The analysis is at the knee level, not participant level (bilateral participants included as two individual knees). The "Overall Number of Participants Analyzed" is the number of study participants at 6 weeks; the "Overall Number of Units Analyzed" refers to the number of knees with data available for analysis at each follow-up timepoint.

This is a binary endpoint in which a knee is either a "success" or "failure".

To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.

1. Absence of osteolysis

2. No migration/subsidence of any femoral or tibial component

3. Absence of fractured component

Conversely, a radiographic failure is defined as follows:

1. Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.

2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.

3. A component fracture

Outcome measures

Measure	Oxford Cementless Partial Knee n=235 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=129 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Number of Knees Which Met the Criteria for Radiographic Success 6 Week	235 Knees	129 Knees
Number of Knees Which Met the Criteria for Radiographic Success 6 Month	208 Knees	115 Knees
Number of Knees Which Met the Criteria for Radiographic Success 1 Year	208 Knees	113 Knees
Number of Knees Which Met the Criteria for Radiographic Success 2 Year	180 Knees	103 Knees
Number of Knees Which Met the Criteria for Radiographic Success 3 Year	147 Knees	79 Knees
Number of Knees Which Met the Criteria for Radiographic Success 4 Year	99 Knees	49 Knees
Number of Knees Which Met the Criteria for Radiographic Success 5 Year	63 Knees	32 Knees
Number of Knees Which Met the Criteria for Radiographic Success 6 Year	23 Knees	14 Knees
Number of Knees Which Met the Criteria for Radiographic Success 7 Year	1 Knees	—

SECONDARY outcome

Timeframe: 6 weeks, 6 months, and annually thereafter until study completion

Population: This analysis is done at the knee-level, not participant level. Bilateral participants were allowed in the study. The "Overall Number of Participants Analyzed" is the number of study subjects analyzed (some with unilateral and some with bilateral knees); the "Overall Number of Units Analyzed" refers to the number of knees analzyed. Also, not every participant returned for every follow-up visit. The "Number Analyzed" in each row/visit below shows the number of knees analyzed at each follow-up.

At each postoperative assessment using the Analysis Windows, patients were asked to indicate their level of satisfaction with the operated knee. The potential outcomes were Very Satisfied, Satisfied, Uncertain and Unsatisfied.

Outcome measures

Measure	Oxford Cementless Partial Knee n=237 Knees Oxford Partial Knee implanted WITHOUT bone cement. Oxford Cementless Partial Knee: Oxford Partial Knee applied without bone cement.	Oxford Cemented Partial Knee n=132 Knees Oxford Partial Knee applied WITH bone cement. Oxford Cemented Partial Knee: Oxford Partial Knee applied with bone cement.
Patient Assessment of Satisfaction 6 Years · Satisfied	4 Knees	0 Knees
Patient Assessment of Satisfaction 6 Week · Very Satisfied	151 Knees	95 Knees
Patient Assessment of Satisfaction 6 Week · Satisfied	60 Knees	27 Knees
Patient Assessment of Satisfaction 6 Week · Uncertain	23 Knees	9 Knees
Patient Assessment of Satisfaction 6 Week · Unsatisfied	3 Knees	1 Knees
Patient Assessment of Satisfaction 6 Month · Very Satisfied	166 Knees	95 Knees
Patient Assessment of Satisfaction 6 Month · Satisfied	35 Knees	20 Knees
Patient Assessment of Satisfaction 6 Month · Uncertain	19 Knees	5 Knees
Patient Assessment of Satisfaction 6 Month · Unsatisfied	2 Knees	3 Knees
Patient Assessment of Satisfaction 1 Year · Very Satisfied	156 Knees	93 Knees
Patient Assessment of Satisfaction 1 Year · Satisfied	38 Knees	17 Knees
Patient Assessment of Satisfaction 1 Year · Uncertain	8 Knees	3 Knees
Patient Assessment of Satisfaction 1 Year · Unsatisfied	2 Knees	1 Knees
Patient Assessment of Satisfaction 2 Years · Very Satisfied	158 Knees	100 Knees
Patient Assessment of Satisfaction 2 Years · Satisfied	27 Knees	12 Knees
Patient Assessment of Satisfaction 2 Years · Uncertain	8 Knees	3 Knees
Patient Assessment of Satisfaction 2 Years · Unsatisfied	1 Knees	1 Knees
Patient Assessment of Satisfaction 3 Years · Very Satisfied	143 Knees	76 Knees
Patient Assessment of Satisfaction 3 Years · Satisfied	17 Knees	3 Knees
Patient Assessment of Satisfaction 3 Years · Uncertain	4 Knees	3 Knees
Patient Assessment of Satisfaction 3 Years · Unsatisfied	1 Knees	1 Knees
Patient Assessment of Satisfaction 4 Years · Very Satisfied	89 Knees	51 Knees
Patient Assessment of Satisfaction 4 Years · Satisfied	16 Knees	1 Knees
Patient Assessment of Satisfaction 4 Years · Uncertain	2 Knees	2 Knees
Patient Assessment of Satisfaction 4 Years · Unsatisfied	0 Knees	0 Knees
Patient Assessment of Satisfaction 5 Years · Very Satisfied	53 Knees	32 Knees
Patient Assessment of Satisfaction 5 Years · Satisfied	8 Knees	0 Knees
Patient Assessment of Satisfaction 5 Years · Uncertain	3 Knees	2 Knees
Patient Assessment of Satisfaction 5 Years · Unsatisfied	1 Knees	0 Knees
Patient Assessment of Satisfaction 6 Years · Very Satisfied	24 Knees	13 Knees
Patient Assessment of Satisfaction 6 Years · Uncertain	2 Knees	0 Knees
Patient Assessment of Satisfaction 6 Years · Unsatisfied	0 Knees	1 Knees
Patient Assessment of Satisfaction 7 Years · Very Satisfied	1 Knees	—
Patient Assessment of Satisfaction 7 Years · Satisfied	0 Knees	—
Patient Assessment of Satisfaction 7 Years · Uncertain	0 Knees	—
Patient Assessment of Satisfaction 7 Years · Unsatisfied	0 Knees	—

Adverse Events

Oxford Cementless Partial Knee

Serious events: 17 serious events

Other events: 114 other events

Deaths: 3 deaths

Oxford Cemented Partial Knee

Serious events: 10 serious events

Other events: 53 other events

Deaths: 9 deaths

Serious adverse events

Measure	Oxford Cementless Partial Knee n=207 participants at risk Oxford Partial Knee implanted WITHOUT bone cement	Oxford Cemented Partial Knee n=114 participants at risk Oxford Partial Knee applied WITH bone cement
Musculoskeletal and connective tissue disorders Avascular Necrosis	0.48% 1/207 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Bearing Dislocation/Disassociation	0.97% 2/207 • Number of events 2 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	1.8% 2/114 • Number of events 2 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Skin and subcutaneous tissue disorders Cellulitis/Redness/Blistering	0.00% 0/207 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Infections and infestations Deep Wound Infection	0.48% 1/207 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Musculoskeletal and connective tissue disorders Effusion/Swelling/Edema	0.97% 2/207 • Number of events 2 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Femoral Implant Loosening	0.48% 1/207 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Musculoskeletal and connective tissue disorders Hemarthrosis/Hemarthritis	0.00% 0/207 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Vascular disorders Hematoma	0.97% 2/207 • Number of events 2 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Surgical and medical procedures Loose body and/or Osteophyte Removal	0.00% 0/207 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Other Ipsilateral Knee Related Adverse Event	1.9% 4/207 • Number of events 5 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Pain (progressive/persistent)	0.48% 1/207 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	1.8% 2/114 • Number of events 3 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Musculoskeletal and connective tissue disorders Progressive Disease in Contralateral Compartment	0.00% 0/207 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Subsidence	0.97% 2/207 • Number of events 2 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.88% 1/114 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Tibial Fracture	1.9% 4/207 • Number of events 4 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Wound Dehiscence	0.48% 1/207 • Number of events 1 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	0.00% 0/114 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)

Other adverse events

Measure	Oxford Cementless Partial Knee n=207 participants at risk Oxford Partial Knee implanted WITHOUT bone cement	Oxford Cemented Partial Knee n=114 participants at risk Oxford Partial Knee applied WITH bone cement
Musculoskeletal and connective tissue disorders Clicking/Popping/Crepitus/Grinding	6.3% 13/207 • Number of events 15 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	3.5% 4/114 • Number of events 4 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Musculoskeletal and connective tissue disorders Effusion/Swelling/Edema	14.0% 29/207 • Number of events 33 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	7.9% 9/114 • Number of events 11 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Other Ipsilateral Knee Related Adverse Event	17.4% 36/207 • Number of events 45 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	15.8% 18/114 • Number of events 27 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
General disorders Pain (progressive/persistent)	24.2% 50/207 • Number of events 63 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	19.3% 22/114 • Number of events 30 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)
Injury, poisoning and procedural complications Traumatic Injury (Study Knee)	7.7% 16/207 • Number of events 21 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)	7.0% 8/114 • Number of events 9 • AEs were collected from post-op until study completion (up to 7 years for the longest-enrolled participants). Adverse Event Case Report Form (worksheet)

Additional Information

Hillary Overholser

Clinical Affairs Associate Director

Phone: 574-933-4180

Email: hillary.overholser@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee Each participating PI has signed a Clinical Trial Agreement and results are not publicly available until FDA provides approval/closure of the study.
• Publication restrictions are in place

Restriction type: OTHER