Trial Outcomes & Findings for ATTUNE Cementless FB Tibial Base Clinical Study (NCT NCT04630262)
NCT ID: NCT04630262
Last Updated: 2025-03-04
Results Overview
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
TERMINATED
NA
80 participants
through study completion, up to 10 months
2025-03-04
Participant Flow
Eighty patients were consented and enrolled. Fifty-nine subjects underwent surgery. All subjects have now been discontinued from the study.
Eighty patients were consented and enrolled. Fifty-nine subjects underwent surgery. All subjects have now been discontinued from the study.
Participant milestones
| Measure |
ATTUNE Cementless Fixed Bearing
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
ATTUNE Cementless Fixed Bearing
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Overall Study
Intraoperative Screen Failure
|
5
|
|
Overall Study
Study terminated prematurely
|
71
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
ATTUNE Cementless FB Tibial Base Clinical Study
Baseline characteristics by cohort
| Measure |
ATTUNE Cementless Fixed Bearing
n=80 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 8.95 • n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
|
Body Mass Index
|
32.9 kg/m2
STANDARD_DEVIATION 6.43 • n=99 Participants
|
PRIMARY outcome
Timeframe: through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsThis measure will assess the percentage of knees with reported AEs throughout the duration of the study.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=80 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Measure of Knees With Adverse Events
|
13.8 % of Knees with AEs
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: 6 subjects experienced at least 1 AE
This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=6 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Mean Number of Adverse Events Per Knee for Knees With Reported AEs
|
1.83 Mean Number of AEs per Knee
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: There were no reported device deficiencies.
This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=59 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Measure of Knees With Device Deficiencies
|
0.0 % of Knees with Device Deficiencies
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: There were no occurrences of device deficiencies reported.
This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=59 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Mean Number of Device Deficiencies Per Knee
|
0.0 Mean # of DDs per knee
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 months.Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 6 weeksPopulation: This includes analysis for all subjects with scorable KSS forms. Not all visits yielded scorable forms. For all categories, higher values are considered better than lower values.
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=42 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
6 Week Knee Society Score
Alignment Subscore: Max 25 (more aligned), Min 0; Knee Alignment
|
23.3 Scores on a scale
Standard Deviation 7.54
|
|
6 Week Knee Society Score
Instability Subscore: Max 25 (more stable), Min 0; Stability in the Coronal and Sagittal Axis.
|
24.8 Scores on a scale
Standard Deviation 1.08
|
|
6 Week Knee Society Score
Joint Motion Subscore: Max 25 (more degrees of motion), Min 0; Degrees of Joint Motion.
|
15.71 Scores on a scale
Standard Deviation 2.381
|
|
6 Week Knee Society Score
Symptoms Subscore: Max 25 (least pain), Min 0; Patient Rating of pain with walking.
|
15.5 Scores on a scale
Standard Deviation 5.18
|
|
6 Week Knee Society Score
Objective Total Score: Max 100 (best), Min 0; Total Alignment, Instability, Motion, and Symptoms.
|
81.45 Scores on a scale
Standard Deviation 5.510
|
|
6 Week Knee Society Score
Patient Satisfaction Total Score: Max 40 (best), Min 0; Measure of Patient's Level of Satisfaction
|
25.1 Scores on a scale
Standard Deviation 7.25
|
|
6 Week Knee Society Score
Patient Expectation Total Score: Max 15 (best), Min 0; Patient's Expectations the Surgery
|
9.7 Scores on a scale
Standard Deviation 2.98
|
|
6 Week Knee Society Score
Patient Function Total Score: Max 100 (best), Min 0; Walking, Standing, and Other Activities.
|
38.4 Scores on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 MonthsPopulation: This includes analysis for all subjects with scorable KSS forms. Not all visits yielded scorable forms. For all categories, higher values are considered better than lower values.
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=10 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
6 Month Knee Society Score
Joint Motion Subscore: Max 25 (more degrees of motion), Min 0; Degrees of Joint Motion.
|
18.87 Scores on a scale
Standard Deviation 3.477
|
|
6 Month Knee Society Score
Alignment Subscore: Max 25 (more aligned), Min 0; Knee Alignment
|
25.0 Scores on a scale
Standard Deviation 0.00
|
|
6 Month Knee Society Score
Instability Subscore: Max 25 (more stable), Min 0; Stability in the Coronal and Sagittal Axis.
|
24.4 Scores on a scale
Standard Deviation 1.67
|
|
6 Month Knee Society Score
Symptoms Subscore: Max 25 (least pain), Min 0; Patient Rating of pain with walking.
|
20.0 Scores on a scale
Standard Deviation 4.36
|
|
6 Month Knee Society Score
Objective Total Score: Max 100 (best), Min 0; Total Alignment, Instability, Motion, and Symptoms.
|
88.31 Scores on a scale
Standard Deviation 5.367
|
|
6 Month Knee Society Score
Patient Satisfaction Total Score: Max 40 (best), Min 0; Patient's Level of Satisfaction
|
32.4 Scores on a scale
Standard Deviation 5.56
|
|
6 Month Knee Society Score
Patient Expectation Total Score: Max 15 (best), Min 0; Patient's Expectations the Surgery
|
12.8 Scores on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint. For all categories, higher values are considered better than lower values.
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 6 weeksPopulation: Analysis not completed due to early closure of the study.
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=41 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain Subscore: Max 100 (best), Min 0; Patient Pain Rating.
|
60.65 Scores on a scale
Standard Deviation 16.403
|
|
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms Subscore: Max 100 (best), Min 0; Patient Knee Symptoms.
|
57.13 Scores on a scale
Standard Deviation 14.293
|
|
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Activities of Daily Living Function Subscore: Max 100 (best), Min 0: Patient's ability to do ADLs.
|
66.75 Scores on a scale
Standard Deviation 14.937
|
|
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Sports and Recreation Subscore: Max 100 (best), Min 0; Ability to do Sports and Recreation.
|
26.49 Scores on a scale
Standard Deviation 18.517
|
|
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Quality of Life Subscore: Max 100 (best), Min 0; Patient Measure of Quality of Life.
|
45.73 Scores on a scale
Standard Deviation 16.022
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 MonthsPopulation: Analysis not completed due to early closure of the study.
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=10 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Quality of Life Subscore: Max 100 (best), Min 0; Patient Measure of Quality of Life.
|
68.96 Scores on a scale
Standard Deviation 21.594
|
|
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain Subscore: Max 100 (best), Min 0; Patient Pain Rating.
|
81.11 Scores on a scale
Standard Deviation 20.108
|
|
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms Subscore: Max 100 (best), Min 0; Patient Knee Symptoms.
|
61.07 Scores on a scale
Standard Deviation 9.737
|
|
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Activities of Daily Living Function Subscore: Max 100 (best), Min 0: Patient's ability to do ADLs.
|
82.50 Scores on a scale
Standard Deviation 16.382
|
|
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Sports and Recreation Subscore: Max 100 (best), Min 0; Ability to do Sports and Recreation.
|
52.50 Scores on a scale
Standard Deviation 23.244
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 6 weeksPopulation: Analysis not completed due to early closure of the study.
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=41 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Week Forgotten Joint Score (FJS-12)
|
20.07 Scores on a scale
Standard Deviation 17.701
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 monthsPopulation: Analysis not completed due to early closure of the study.
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=9 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Month Forgotten Joint Score (FJS-12)
|
49.54 Scores on a scale
Standard Deviation 16.463
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 6 weeksPopulation: Analysis not completed due to early closure of the study.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=40 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EQ VAS Total Health Score: Max 100 (best), Min 0; Patient's perception of their health.
|
76.6 Scores on a scale
Standard Deviation 11.81
|
|
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EQ-5D-5L Index Value: Max 1.0 (best), Min 0.0; Measure of patient health for appraisal.
|
0.7398 Scores on a scale
Standard Deviation 0.1326
|
SECONDARY outcome
Timeframe: Through study completion, up to 6 monthsPopulation: Analysis not completed due to early closure of the study.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=9 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EQ VAS Total Health Score: Max 100 (best), Min 0; Patient's perception of their health.
|
85.6 Scores on a scale
Standard Deviation 12.10
|
|
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
EQ-5D-5L Index Value: Max 1.0 (best), Min 0.0; Measure of patient health for appraisal.
|
0.8780 Scores on a scale
Standard Deviation 0.0738
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 6 MonthsRate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Outcome measures
| Measure |
ATTUNE Cementless Fixed Bearing
n=50 Participants
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Six Month Investigator-conducted Radiographic Analysis
Osteolysis
|
2.0 % of Knees with Significant Findings
|
|
Six Month Investigator-conducted Radiographic Analysis
Radiolucency
|
2.0 % of Knees with Significant Findings
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, up to 10 monthsPopulation: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Outcome measures
Outcome data not reported
Adverse Events
ATTUNE Cementless Fixed Bearing
Serious adverse events
| Measure |
ATTUNE Cementless Fixed Bearing
n=80 participants at risk
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Right Knee Arthrofibrosis
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
Other adverse events
| Measure |
ATTUNE Cementless Fixed Bearing
n=80 participants at risk
ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling on Left Ankle
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Bruising on Left Leg
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Numbness on Lateral Side
|
2.5%
2/80 • Number of events 2 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Limited Range of Motion
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Pins and Needles L Knee
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
General disorders
Fatigue
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Cemented the Tibial Base
|
1.2%
1/80 • Number of events 1 • Adverse events were monitored from the preoperative visit to study closure, up to 10 months.
All serious, device-related, and/or procedure-related adverse events were reported throughout the duration of the study.
|
Additional Information
Kelly Francher, Staff Clinical Research Scientist
DePuy Synthes
Results disclosure agreements
- Principal investigator is a sponsor employee Data collection in this study was conducted according to the Clinical Investigation Plan and all applicable regulations unless otherwise stated. Data is not anticipated to be used for publication or as the basis for future regulatory submissions except as part of routine post-market surveillance on the associated products. The database was closed without source data verification or final data cleanup. No statistical analysis of this data will occur.
- Publication restrictions are in place
Restriction type: OTHER