Trial Outcomes & Findings for Retrospective Simplex High Viscosity (HV) Bone Cement Study (NCT NCT05659329)
NCT ID: NCT05659329
Last Updated: 2026-01-12
Results Overview
A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
24 months
Results posted on
2026-01-12
Participant Flow
This was a retrospective study with planned 100 subjects per group. Recruitment was stopped in the Non-medicated Simplex HV group with 97 subjects because there were no additional eligible subjects.
In the non-medicated Simplex HV group further three of the 97 subjects were excluded after enrollment as two subjects did not receive the study device and one subject met an exclusion criterion (Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days))
Participant milestones
| Measure |
Non-medicated Simplex HV
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
101
|
|
Overall Study
COMPLETED
|
95
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-medicated Simplex HV
n=95 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=101 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Simplex HV Bone Cement with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
66 years
STANDARD_DEVIATION 8.84 • n=95 Participants
|
71.8 years
STANDARD_DEVIATION 7.83 • n=101 Participants
|
68.97 years
STANDARD_DEVIATION 8.83 • n=196 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=95 Participants
|
58 Participants
n=101 Participants
|
123 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=95 Participants
|
43 Participants
n=101 Participants
|
73 Participants
n=196 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
95 Participants
n=95 Participants
|
0 Participants
n=101 Participants
|
95 Participants
n=196 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=95 Participants
|
101 Participants
n=101 Participants
|
101 Participants
n=196 Participants
|
|
Height cm
|
165 centimeter
STANDARD_DEVIATION 10.17 • n=95 Participants • In the Simplex HV Gentamicin group, for some subjects height was not available in retrospective data collection.
|
166 centimeter
STANDARD_DEVIATION 9.24 • n=101 Participants • In the Simplex HV Gentamicin group, for some subjects height was not available in retrospective data collection.
|
165.4 centimeter
STANDARD_DEVIATION 9.7 • n=196 Participants • In the Simplex HV Gentamicin group, for some subjects height was not available in retrospective data collection.
|
|
Weight kg
|
91.0 kilogram
STANDARD_DEVIATION 19.65 • n=95 Participants
|
83.4 kilogram
STANDARD_DEVIATION 14.82 • n=101 Participants
|
87.1 kilogram
STANDARD_DEVIATION 17.71 • n=196 Participants
|
|
BMI
|
33.3 kg/m^2
STANDARD_DEVIATION 5.94 • n=95 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 4.73 • n=101 Participants
|
31.87 kg/m^2
STANDARD_DEVIATION 5.53 • n=196 Participants
|
|
Operative side
Left side
|
47 Participants
n=95 Participants
|
44 Participants
n=101 Participants
|
91 Participants
n=196 Participants
|
|
Operative side
Right side
|
48 Participants
n=95 Participants
|
57 Participants
n=101 Participants
|
105 Participants
n=196 Participants
|
PRIMARY outcome
Timeframe: 24 monthsA successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.
Outcome measures
| Measure |
Non-medicated Simplex HV
n=95 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=101 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Number of Participants With Successful Application of Bone Cement
|
95 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: pre-op, 2 years, 5 years (optional)Population: The retrospective study approach did not allow for full KSS data collection. Range of motion data available were collected for analysis.
The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg).
Outcome measures
| Measure |
Non-medicated Simplex HV
n=90 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=26 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Knee Society Score (KSS) Pain Motion Score: Range of Motion
Pre-op Range of motion (ROM)
|
108.59 degrees
Standard Deviation 12.74
|
101.16 degrees
Standard Deviation 14.19
|
|
Knee Society Score (KSS) Pain Motion Score: Range of Motion
2 years ROM
|
110.48 degrees
Standard Deviation 12.48
|
110.32 degrees
Standard Deviation 11.40
|
|
Knee Society Score (KSS) Pain Motion Score: Range of Motion
5 years ROM
|
113.37 degrees
Standard Deviation 13.35
|
114.81 degrees
Standard Deviation 8.74
|
SECONDARY outcome
Timeframe: Pre-operative, 2 years, 5 years (optional)Population: The retrospective study approach did not allow for full KSS data collection. Pain data available were collected for analysis.
This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects.
Outcome measures
| Measure |
Non-medicated Simplex HV
n=90 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=26 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
KSS Pain Motion Score: Pain
Pre-operative Pain · No pain
|
0 Participants
|
1 Participants
|
|
KSS Pain Motion Score: Pain
Pre-operative Pain · Mild or occasional pain
|
11 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Pain
Pre-operative Pain · Moderate continual pain
|
34 Participants
|
6 Participants
|
|
KSS Pain Motion Score: Pain
Pre-operative Pain · Moderate occasional pain
|
24 Participants
|
1 Participants
|
|
KSS Pain Motion Score: Pain
Pre-operative Pain · Severe pain
|
21 Participants
|
18 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 2 years · No pain
|
49 Participants
|
2 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 2 years · Mild or occasional pain
|
26 Participants
|
5 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 2 years · Moderate continual pain
|
3 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 2 years · Moderate occasional pain
|
4 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 2 years · Severe pain
|
0 Participants
|
1 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 5 years · No pain
|
29 Participants
|
6 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 5 years · Mild or occasional pain
|
17 Participants
|
2 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 5 years · Moderate continual pain
|
1 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 5 years · Moderate occasional pain
|
2 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Pain
Pain at 5 years · Severe pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-operative, 2 years, 5 years (optional)Population: The retrospective study approach did not allow for full KSS data collection. Use of walking aids data available were collected for analysis.
Pre- and postoperative use of walking aids
Outcome measures
| Measure |
Non-medicated Simplex HV
n=69 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=23 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
KSS Function Score: Walking Aids
Pre-operative walking aids use · Cane
|
23 Participants
|
12 Participants
|
|
KSS Function Score: Walking Aids
Pre-operative walking aids use · Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair
|
3 Participants
|
1 Participants
|
|
KSS Function Score: Walking Aids
Pre-operative walking aids use · Two canes, one crutch
|
0 Participants
|
1 Participants
|
|
KSS Function Score: Walking Aids
Pre-operative walking aids use · None
|
43 Participants
|
9 Participants
|
|
KSS Function Score: Walking Aids
Walking aids use at 2 years · Cane
|
13 Participants
|
0 Participants
|
|
KSS Function Score: Walking Aids
Walking aids use at 2 years · Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair
|
2 Participants
|
0 Participants
|
|
KSS Function Score: Walking Aids
Walking aids use at 2 years · Two canes, one crutch
|
0 Participants
|
0 Participants
|
|
KSS Function Score: Walking Aids
Walking aids use at 2 years · None
|
52 Participants
|
2 Participants
|
|
KSS Function Score: Walking Aids
Walking aids use at 5 years · Cane
|
8 Participants
|
—
|
|
KSS Function Score: Walking Aids
Walking aids use at 5 years · Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair
|
2 Participants
|
—
|
|
KSS Function Score: Walking Aids
Walking aids use at 5 years · Two canes, one crutch
|
0 Participants
|
—
|
|
KSS Function Score: Walking Aids
Walking aids use at 5 years · None
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: pre-operative, 2 years, 5 years (optional)Population: The retrospective study approach did not allow for full KSS data collection. Walking ability data available were collected for analysis.
Pre- and post-operative walking ability
Outcome measures
| Measure |
Non-medicated Simplex HV
n=52 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=24 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
KSS Function Score: Walking
Pre-operative walking ability · Housebound
|
1 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Pre-operative walking ability · Below 5 blocks (<500m/<1640 feet)
|
48 Participants
|
13 Participants
|
|
KSS Function Score: Walking
Pre-operative walking ability · 5-10 blocks (500m - 1000m/1640-3280 feet)
|
0 Participants
|
7 Participants
|
|
KSS Function Score: Walking
Pre-operative walking ability · Over 10 blocks (>1000m/>3280 feet)
|
2 Participants
|
2 Participants
|
|
KSS Function Score: Walking
Pre-operative walking ability · Unlimited
|
1 Participants
|
2 Participants
|
|
KSS Function Score: Walking
Walking ability at 2 years · Housebound
|
2 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 2 years · Below 5 blocks (<500m/<1640 feet)
|
2 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 2 years · 5-10 blocks (500m - 1000m/1640-3280 feet)
|
0 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 2 years · Over 10 blocks (>1000m/>3280 feet)
|
3 Participants
|
1 Participants
|
|
KSS Function Score: Walking
Walking ability at 2 years · Unlimited
|
17 Participants
|
2 Participants
|
|
KSS Function Score: Walking
Walking ability at 5 years · Housebound
|
0 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 5 years · Below 5 blocks (<500m/<1640 feet)
|
1 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 5 years · 5-10 blocks (500m - 1000m/1640-3280 feet)
|
2 Participants
|
1 Participants
|
|
KSS Function Score: Walking
Walking ability at 5 years · Over 10 blocks (>1000m/>3280 feet)
|
0 Participants
|
0 Participants
|
|
KSS Function Score: Walking
Walking ability at 5 years · Unlimited
|
13 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-operative, 2 years, 5 years (optional)Population: The retrospective study approach did not allow for full KSS data collection. Stair climbing ability data available were collected for analysis of non-medicated Simplex HV only.
Pre-and postoperative ability of climbing stairs
Outcome measures
| Measure |
Non-medicated Simplex HV
n=36 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
KSS Function Score: Stairs
Ability to climb stairs at 2 years · Normal up and down
|
15 Participants
|
—
|
|
KSS Function Score: Stairs
Pre-operative ability to climb stairs · Unable
|
22 Participants
|
—
|
|
KSS Function Score: Stairs
Pre-operative ability to climb stairs · Up with rail/unable down
|
0 Participants
|
—
|
|
KSS Function Score: Stairs
Pre-operative ability to climb stairs · Up and down with rail
|
12 Participants
|
—
|
|
KSS Function Score: Stairs
Pre-operative ability to climb stairs · Normal up/down with rail
|
2 Participants
|
—
|
|
KSS Function Score: Stairs
Pre-operative ability to climb stairs · Normal up and down
|
0 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 2 years · Unable
|
0 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 2 years · Up with rail/unable down
|
0 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 2 years · Up and down with rail
|
2 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 2 years · Normal up/down with rail
|
1 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 5 years · Unable
|
1 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 5 years · Up with rail/unable down
|
0 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 5 years · Up and down with rail
|
2 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 5 years · Normal up/down with rail
|
1 Participants
|
—
|
|
KSS Function Score: Stairs
Ability to climb stairs at 5 years · Normal up and down
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: pre-op, 2 years, 5 years (optional)Population: Due to the retrospective study approach, the site of the Non-medicated Simplex HV arm did not collect OKS data and therefore OKS data cannot be presented for this site, whereas the site for the Gentamicin Simplex HV arm did collect OKS data which are presented.
The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function.
Outcome measures
| Measure |
Non-medicated Simplex HV
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=101 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Oxford Knee Score (OKS) Results
pre-operative OKS
|
—
|
18.96 score on a scale
Standard Deviation 7.79
|
|
Oxford Knee Score (OKS) Results
2 years OKS
|
—
|
39.27 score on a scale
Standard Deviation 7.92
|
|
Oxford Knee Score (OKS) Results
5 years OKS
|
—
|
39.38 score on a scale
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: pre-operative, 2 years, 5 years (optional)Population: The retrospective study approach in the Non-medicated Simplex HV study arm did not allow for full KSS Stability data collection as not all data were collected at 2 and 5 years.
This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability \< 5 mm and medio-lateral (m/l) stability \< 5° means mild increase in laxity compared to the contralateral knee.
Outcome measures
| Measure |
Non-medicated Simplex HV
n=87 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=1 Participants
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
KSS Pain Motion Score: Stability
preoperative a/p <5mm and m/l <5° stability
|
87 Participants
|
1 Participants
|
|
KSS Pain Motion Score: Stability
2 years a/p <5mm and m/l <5° stability
|
81 Participants
|
0 Participants
|
|
KSS Pain Motion Score: Stability
5 years a/p <5mm and m/l <5° stability
|
52 Participants
|
0 Participants
|
Adverse Events
Non-medicated Simplex HV
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
Gentamicin Simplex HV
Serious events: 21 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-medicated Simplex HV
n=95 participants at risk
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=101 participants at risk
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Blood and lymphatic system disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
2.0%
2/101 • Number of events 2 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Cardiac disorders
Non-operative
|
2.1%
2/95 • Number of events 2 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
2.0%
2/101 • Number of events 3 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Gastrointestinal disorders
Non-operative
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Immune system disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Infections and infestations
Non-operative
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Musculoskeletal and connective tissue disorders
Non-operative
|
2.1%
2/95 • Number of events 2 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
5.0%
5/101 • Number of events 5 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Nervous system disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Psychiatric disorders
Non-operative
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.00%
0/101 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Renal and urinary disorders
Non-operative
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
3.0%
3/101 • Number of events 3 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Skin and subcutaneous tissue disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Vascular disorders
Non-operative
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.99%
1/101 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
2.0%
2/101 • Number of events 2 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Surgical and medical procedures
Operative site
|
0.00%
0/95 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
3.0%
3/101 • Number of events 3 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
|
Infections and infestations
Operative site
|
1.1%
1/95 • Number of events 1 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
0.00%
0/101 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
Other adverse events
| Measure |
Non-medicated Simplex HV
n=95 participants at risk
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
Gentamicin Simplex HV
n=101 participants at risk
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.
Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Operative site
|
18.9%
18/95 • Number of events 24 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
8.9%
9/101 • Number of events 9 • In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov definition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60