Trial Outcomes & Findings for Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation (NCT NCT00753090)

Last Updated: 2025-01-30

Results Overview

The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: \< 60 points.

Recruitment status

COMPLETED

Study phase

Target enrollment

326 participants

Primary outcome timeframe

2 years

Results posted on

2025-01-30

Participant Flow

Patients who met the criteria were introduced the study by surgeons and got a written information. By the next visit, the surgeons asked if the patients wanted to participate, and if yes, both signed the informed consent. Dutch sites performed randomized controlled trial (RCT). The UK site enrolled the Vanguard DDRP cases only and the French site enrolled both cases without randomization. The UK site was closed after 3 year follow-up, and the French site became unresponsive in 2020.

Participant milestones

Participant milestones
Measure	VG DDRP (Trial Group) This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Overall Study STARTED	209	117
Overall Study COMPLETED	41	21
Overall Study NOT COMPLETED	168	96

Reasons for withdrawal

Reasons for withdrawal
Measure	VG DDRP (Trial Group) This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Overall Study Withdrawal by Subject	10	10
Overall Study Death	17	6
Overall Study Study Prosthesis Removed	12	3
Overall Study Lost to Follow-up	2	2
Overall Study Other	127	75

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.	Total n=326 Participants Total of all reporting groups
Age, Continuous	70.1 years n=209 Participants	69.0 years n=117 Participants	69.55 years n=326 Participants
Sex: Female, Male Female	134 Participants n=209 Participants	67 Participants n=117 Participants	201 Participants n=326 Participants
Sex: Female, Male Male	75 Participants n=209 Participants	50 Participants n=117 Participants	125 Participants n=326 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Reason for surgery/indication Osteoarthritis	200 Participants n=209 Participants	115 Participants n=117 Participants	315 Participants n=326 Participants
Reason for surgery/indication Rheumatoid arthritis	3 Participants n=209 Participants	2 Participants n=117 Participants	5 Participants n=326 Participants
Reason for surgery/indication Traumatic arthritis	1 Participants n=209 Participants	0 Participants n=117 Participants	1 Participants n=326 Participants
Reason for surgery/indication Other	5 Participants n=209 Participants	0 Participants n=117 Participants	5 Participants n=326 Participants
BMI	29.7 kg/m² STANDARD_DEVIATION 5.5 • n=187 Participants • Available demographic information is entered.	30.0 kg/m² STANDARD_DEVIATION 4.3 • n=115 Participants • Available demographic information is entered.	29.85 kg/m² STANDARD_DEVIATION 4.9 • n=302 Participants • Available demographic information is entered.

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Knee Society Score Objective score	89.7 score on a scale Standard Deviation 12.0	91.8 score on a scale Standard Deviation 9.8
Knee Society Score Function score	89.9 score on a scale Standard Deviation 13.9	83.2 score on a scale Standard Deviation 21.6

SECONDARY outcome

Timeframe: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years

Population: Numbers of participants for both groups are lower than the enrolled number of patients, especially pre-op. This is because leg extension is not being captured for a lot of pre-op cases, and therefore no score could be calculated.

Outcome measures

Outcome measures
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Knee Society Score Preop (Objective Score)	51.2 score on a scale Standard Deviation 13.7	53.2 score on a scale Standard Deviation 15.8
Knee Society Score 6 Week (Objective Score)	72.4 score on a scale Standard Deviation 19.2	77.5 score on a scale Standard Deviation 16.7
Knee Society Score 6 Month (Objective Score)	81.7 score on a scale Standard Deviation 15.6	86.4 score on a scale Standard Deviation 11.1
Knee Society Score 1 Year (Objective Score)	85.8 score on a scale Standard Deviation 14.8	88.9 score on a scale Standard Deviation 10.2
Knee Society Score 2 Year (Objective Score)	89.7 score on a scale Standard Deviation 12.0	91.8 score on a scale Standard Deviation 9.8
Knee Society Score 3 Year (Objective Score)	85.4 score on a scale Standard Deviation 13.7	89.5 score on a scale Standard Deviation 8.5
Knee Society Score 5 Year (Objective Score)	85.7 score on a scale Standard Deviation 13.8	92.6 score on a scale Standard Deviation 6.6
Knee Society Score 7 Year (Objective Score)	86.8 score on a scale Standard Deviation 12.3	90.2 score on a scale Standard Deviation 6.8
Knee Society Score 10 Year (Objective Score)	87.6 score on a scale Standard Deviation 13.0	90.6 score on a scale Standard Deviation 7.6
Knee Society Score Preop (Function Score)	51.9 score on a scale Standard Deviation 17.0	55.5 score on a scale Standard Deviation 16.7
Knee Society Score 6 Week (Function Score)	64.1 score on a scale Standard Deviation 19.9	62.7 score on a scale Standard Deviation 20.3
Knee Society Score 6 Month (Function Score)	79.8 score on a scale Standard Deviation 18.7	78.1 score on a scale Standard Deviation 16.7
Knee Society Score 1 Year (Function Score)	86.6 score on a scale Standard Deviation 17.4	84.2 score on a scale Standard Deviation 16.8
Knee Society Score 2 Year (Function Score)	89.9 score on a scale Standard Deviation 13.9	83.2 score on a scale Standard Deviation 21.6
Knee Society Score 3 Year (Function Score)	81.3 score on a scale Standard Deviation 22.1	86.9 score on a scale Standard Deviation 16.1
Knee Society Score 5 Year (Function Score)	79.8 score on a scale Standard Deviation 25.1	90.1 score on a scale Standard Deviation 12.8
Knee Society Score 7 Year (Function Score)	70.5 score on a scale Standard Deviation 24.8	67.9 score on a scale Standard Deviation 27.7
Knee Society Score 10 Year (Function Score)	90.0 score on a scale Standard Deviation 23.0	88.3 score on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years postoperative

Population: Note that 7 and 10-years radiographic data is limited, this is because the COVID pandemic was impacting those visits. Therefore, the 7 and 10-years information is limited, and results must be interpreted with care.

Assessment of patient x-rays by each site investigator: Total varus angle. This is defined as the sum of the femoral flexion (the angle between the femoral median axis and the tibial median axis) and the tibial angle (the angle between the anatomical axis of the femur and the tibia in the anteroposterior view of the knee joint) minus 180 degrees.

Outcome measures

Outcome measures
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Radiographic Evaluation: Total Varus Angle 1 Year Total Valgus Angle	3.1 Degree Standard Deviation 3.7	3.9 Degree Standard Deviation 3.3
Radiographic Evaluation: Total Varus Angle 6 Weeks Total Valgus Angle	3.1 Degree Standard Deviation 3.5	3.5 Degree Standard Deviation 3.7
Radiographic Evaluation: Total Varus Angle 6 Months Total Valgus Angle	2.9 Degree Standard Deviation 3.7	3.9 Degree Standard Deviation 3.2
Radiographic Evaluation: Total Varus Angle 2 Year Total Valgus Angle	2.9 Degree Standard Deviation 3.4	3.1 Degree Standard Deviation 2.9
Radiographic Evaluation: Total Varus Angle 3 Year Total Valgus Angle	3.2 Degree Standard Deviation 4.1	3.4 Degree Standard Deviation 3.8
Radiographic Evaluation: Total Varus Angle 5 Year Total Valgus Angle	2.0 Degree Standard Deviation 4.2	2.3 Degree Standard Deviation 3.2
Radiographic Evaluation: Total Varus Angle 7 Year Total Valgus Angle	-0.7 Degree Standard Deviation 4.2	3.0 Degree Standard Deviation 3.0
Radiographic Evaluation: Total Varus Angle 10 Year Total Valgus Angle	6.6 Degree Standard Deviation 4.1	3.4 Degree Standard Deviation 3.0

SECONDARY outcome

Timeframe: 6 weeks, 6 months, 1, 2, 3, 5, 7 and 10 years postoperative

Assessment of patient x-rays by each site investigator: Radiolucency Femoral Radiolucency is defined as the total nr of participants with radiolucency measured on the femur in each of the 7 different zones. Tibia AP Radiolucency is defined as total nr of participants with radiolucency in each of the 7 zones measured in the AP view X-ray Tibia lateral Radiolucency defined as total nr of participants with radiolucency in each of the 3 zones in the lateral view X-ray Patella Radiolucency is defined as total nr of participants with radiolucency in each of the 5 zones

Outcome measures

Outcome measures
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Radiographic Evaluation: Radiolucency 6 Weeks Femoral radiolucency	12 Participants	0 Participants
Radiographic Evaluation: Radiolucency 6 Weeks Tibial AP radiolucency	2 Participants	2 Participants
Radiographic Evaluation: Radiolucency 6 Weeks Tibial Lateral radiolucency	3 Participants	1 Participants
Radiographic Evaluation: Radiolucency 6 Weeks Patella radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 6 Weeks Tibial component migration	2 Participants	0 Participants
Radiographic Evaluation: Radiolucency 6 Weeks Femoral component migration	1 Participants	0 Participants
Radiographic Evaluation: Radiolucency 6 Months Femoral radiolucency	16 Participants	7 Participants
Radiographic Evaluation: Radiolucency 6 Months Tibial AP radiolucency	6 Participants	8 Participants
Radiographic Evaluation: Radiolucency 6 Months Tibial Lateral radiolucency	10 Participants	8 Participants
Radiographic Evaluation: Radiolucency 6 Months Patella radiolucency	0 Participants	1 Participants
Radiographic Evaluation: Radiolucency 6 Months Tibial component migration	2 Participants	0 Participants
Radiographic Evaluation: Radiolucency 6 Months Femoral component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 1 Year Femoral radiolucency	14 Participants	6 Participants
Radiographic Evaluation: Radiolucency 1 Year Tibial AP radiolucency	9 Participants	4 Participants
Radiographic Evaluation: Radiolucency 1 Year Tibial Lateral radiolucency	11 Participants	6 Participants
Radiographic Evaluation: Radiolucency 1 Year Patella radiolucency	3 Participants	0 Participants
Radiographic Evaluation: Radiolucency 1 Year Tibial component migration	1 Participants	1 Participants
Radiographic Evaluation: Radiolucency 1 Year Femoral component migration	0 Participants	1 Participants
Radiographic Evaluation: Radiolucency 2 Year Femoral radiolucency	4 Participants	0 Participants
Radiographic Evaluation: Radiolucency 2 Year Tibial AP radiolucency	4 Participants	1 Participants
Radiographic Evaluation: Radiolucency 2 Year Tibial Lateral radiolucency	2 Participants	0 Participants
Radiographic Evaluation: Radiolucency 2 Year Patella radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 2 Year Tibial component migration	1 Participants	1 Participants
Radiographic Evaluation: Radiolucency 2 Year Femoral component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 3 Year Femoral radiolucency	11 Participants	1 Participants
Radiographic Evaluation: Radiolucency 3 Year Tibial AP radiolucency	7 Participants	0 Participants
Radiographic Evaluation: Radiolucency 3 Year Tibial Lateral radiolucency	5 Participants	0 Participants
Radiographic Evaluation: Radiolucency 3 Year Patella radiolucency	1 Participants	0 Participants
Radiographic Evaluation: Radiolucency 3 Year Tibial component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 3 Year Femoral component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Femoral radiolucency	21 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Tibial AP radiolucency	4 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Tibial Lateral radiolucency	3 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Patella radiolucency	2 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Tibial component migration	3 Participants	0 Participants
Radiographic Evaluation: Radiolucency 5 Year Femoral component migration	3 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Femoral radiolucency	14 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Tibial AP radiolucency	7 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Tibial Lateral radiolucency	5 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Patella radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Tibial component migration	1 Participants	0 Participants
Radiographic Evaluation: Radiolucency 7 Year Femoral component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Femoral radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Tibial AP radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Tibial Lateral radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Patella radiolucency	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Tibial component migration	0 Participants	0 Participants
Radiographic Evaluation: Radiolucency 10 Year Femoral component migration	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 years

Population: The UK site was closed after 3 year follow-up, and the French site became unresponsive in 2020. This explains the low number of long-term follow-up rate.

implant survival at 10 years post surgery and is presented by the number of cases with the implants unrevised

Outcome measures

Outcome measures
Measure	VG DDRP (Trial Group) n=209 Participants This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 Participants This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Survivorship	178 Participants	114 Participants

Adverse Events

VG DDRP (Trial Group)

Serious events: 111 serious events

Other events: 0 other events

Deaths: 17 deaths

VG CR (Control Group)

Serious events: 14 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Lisette Smid

Zimmer Biomet

Phone: 0623956378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	VG DDRP (Trial Group) n=209 participants at risk This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	VG CR (Control Group) n=117 participants at risk This arm utilizes the Vanguard™ Cruciate Retaining Knee.
Vascular disorders Calf Edema	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Cardiac disorders Cardiovascular	1.4% 3/209 • Number of events 3 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Skin and subcutaneous tissue disorders Dermatological	1.9% 4/209 • Number of events 4 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Dislocation/Subluxation	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Vascular disorders DVT	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Gastrointestinal disorders Gastrointestinal	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Vascular disorders Hematological	0.96% 2/209 • Number of events 2 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Surgical and medical procedures Implant Oversized	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Infections and infestations Infection	2.4% 5/209 • Number of events 5 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	1.7% 2/117 • Number of events 2 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Skin and subcutaneous tissue disorders Delayed Wound healing	0.00% 0/209 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.85% 1/117 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Loosening	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Musculoskeletal	6.7% 14/209 • Number of events 16 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	3.4% 4/117 • Number of events 4 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Musculoskeletal (non study joint)	15.3% 32/209 • Number of events 40 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.85% 1/117 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Pain (study Joint)	2.4% 5/209 • Number of events 5 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Psychiatric disorders Psychological	0.96% 2/209 • Number of events 2 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Blood and lymphatic system disorders Pulmonary Embolism	0.96% 2/209 • Number of events 2 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Reflex Sympathetic Syndrome	5.7% 12/209 • Number of events 12 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Respiratory, thoracic and mediastinal disorders respiratory	0.48% 1/209 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.85% 1/117 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders revision of study knee	5.7% 12/209 • Number of events 12 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	2.6% 3/117 • Number of events 3 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Traumatic Injury	2.9% 6/209 • Number of events 7 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Musculoskeletal and connective tissue disorders Traumatic Injury (non study joint)	0.00% 0/209 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.85% 1/117 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.96% 2/209 • Number of events 2 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Nervous system disorders Neurological	0.00% 0/209 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.85% 1/117 • Number of events 1 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.
Skin and subcutaneous tissue disorders Hematoma	1.4% 3/209 • Number of events 3 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.	0.00% 0/117 • All adverse events reported were recorded throughout the participation of the study (Up to 10 years). All adverse events were followed until they have abated, or until a stable situation has been reached. All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded. However, the Adverse Event Case Report Form didn't categorize seriousness of the events, therefore, all reported adverse events are presented as SAE's.