Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty
Brief summary
This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.
Detailed description
The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window. Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis group. The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE Cementless Tibial Base by evaluating type and frequency of Adverse Events and Device Deficiencies, functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1-year timepoint, the change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year timepoints in functional outcomes and quality of life assessments, as measured using additional patient reported outcomes measures (PROMS), implant survivorship of the ATTUNE Cementless FB Tibial base using Kaplan-Meier survival analysis at 1, 2 and 5-year timepoints, and investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 months 1, 2 and 5 years after surgery.
Interventions
DEVICEATTUNE Cementless CR Fixed Bearing
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.
DEVICEATTUNE Cementless PS Fixed Bearing
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
ATTUNE Cementless Fixed Bearing
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 2. Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present. 3. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor. 4. Subject is currently not bedridden. 5. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. 6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.
Exclusion criteria
* a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study . c) Revision knee that was previously enrolled in the study as a primary knee (ipsilateral). d) Subject has participated in a clinical study with an investigational product (drug or device) in the last two (2) years. e) Subject has had surgery on their contralateral knee within six (6) months of study enrolment or has surgery planned on their contralateral knee less than six (6) months of the study surgery. f) Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). g) Active local or systemic infection. h) Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could lead to implant instability, joint neuropathy). i) Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. j) The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces. k) Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. l) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One Year Functional Responder Rate of First 225 Subjects | through study completion, up to 10 months | Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Adverse Events Per Knee for Knees With Reported AEs | Through study completion, up to 10 months | This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study. |
| Measure of Knees With Device Deficiencies | Through study completion, up to 10 months | This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study. |
| Mean Number of Device Deficiencies Per Knee | Through study completion, up to 10 months | This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study. |
| One Year Functional Responder Rate All Subjects | Through study completion, up to 10 months. | Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects. |
| One Year Kaplan-Meier Implant Survivorship | Through study completion, up to 10 months | Number/rate of subjects with all implants remaining implanted at the 1 year timepoint. |
| Two Year Kaplan-Meier Implant Survivorship | Through study completion, up to 10 months | Number/rate of subjects with all implants remaining implanted at the 2- year timepoint. |
| Five Year Kaplan-Meier Implant Survivorship | Through study completion, up to 10 months | Number/rate of subjects with all implants remaining implanted at the 5- year timepoint. |
| 6 Week Knee Society Score | Through study completion, up to 6 weeks | Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. |
| 6 Month Knee Society Score | Through study completion, up to 6 Months | Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. |
| One Year Knee Society Score | Through study completion, up to 10 months | 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. |
| Two Year Knee Society Score | Through study completion, up to 10 months | 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. |
| Five Year Knee Society Score | Through study completion, up to 10 months | 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. |
| Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through study completion, up to 6 weeks | 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. |
| Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through study completion, up to 6 Months | 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. |
| One Year Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through study completion, up to 10 months | 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. |
| Measure of Knees With Adverse Events | Through study completion, up to 10 months | This measure will assess the percentage of knees with reported AEs throughout the duration of the study. |
| Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through study completion, up to 10 months | 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. |
| Six Week Forgotten Joint Score (FJS-12) | Through study completion, up to 6 weeks | 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 |
| Six Month Forgotten Joint Score (FJS-12) | Through study completion, up to 6 months | 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 |
| 1 Year Forgotten Joint Score (FJS-12) | Through study completion, up to 10 months | 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 |
| Two Year Forgotten Joint Score (FJS-12) | Through study completion, up to 10 months | 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 |
| Five Year Forgotten Joint Score (FJS-12) | Through study completion, up to 10 months | 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 |
| Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Through study completion, up to 6 weeks | 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. |
| Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Through study completion, up to 6 months | 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. |
| One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Through study completion, up to 10 months | 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. |
| Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Through study completion, up to 10 months | 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. |
| Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Through study completion, up to 10 months | 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. |
| Six Month Investigator-conducted Radiographic Analysis | Through study completion, up to 6 Months | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. |
| One Year Investigator-conducted Radiographic Analysis | Through study completion, up to 10 months | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. |
| Two Year Investigator-conducted Radiographic Analysis | Through study completion, up to 10 months | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. |
| Five Year Investigator-conducted Radiographic Analysis | Through study completion, up to 10 months | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. |
| Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS) | Through study completion, up to 10 months | 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. |
Countries
United States
Participant flow
Recruitment details
Eighty patients were consented and enrolled. Fifty-nine subjects underwent surgery. All subjects have now been discontinued from the study.
Pre-assignment details
Eighty patients were consented and enrolled. Fifty-nine subjects underwent surgery. All subjects have now been discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| ATTUNE Cementless Fixed Bearing ATTUNE Cementless Femur, ATTUNE Cementless Fixed Bearing Tibial Base, ATTUNE polyethylene insert, ATTUNE Cemented Patella or not resurfaced. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Intraoperative Screen Failure | 5 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Study terminated prematurely | 71 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | ATTUNE Cementless Fixed Bearing |
|---|---|
| Age, Continuous | 63.0 Years STANDARD_DEVIATION 8.95 |
| Body Mass Index | 32.9 kg/m2 STANDARD_DEVIATION 6.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 6 / 80 |
| serious Total, serious adverse events | 1 / 80 |
Outcome results
Primary
One Year Functional Responder Rate of First 225 Subjects
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
Time frame: through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
1 Year Forgotten Joint Score (FJS-12)
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
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
6 Month Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Time frame: Through study completion, up to 6 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 6 Month Knee Society Score | Alignment Subscore: Max 25 (more aligned), Min 0; Knee Alignment | 25.0 Scores on a scale | Standard Deviation 0 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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
6 Week Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Time frame: Through study completion, up to 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 5.51 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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
Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Five Year Forgotten Joint Score (FJS-12)
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
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Five Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Five Year Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Five Year Knee Society Score
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.
Time frame: Through study completion, up to 10 months
Population: 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.
Secondary
Mean Number of Adverse Events Per Knee for Knees With Reported AEs
This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Population: 6 subjects experienced at least 1 AE
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ATTUNE Cementless Fixed Bearing | Mean Number of Adverse Events Per Knee for Knees With Reported AEs | 1.83 Mean Number of AEs per Knee |
Secondary
Mean Number of Device Deficiencies Per Knee
This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Population: There were no occurrences of device deficiencies reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ATTUNE Cementless Fixed Bearing | Mean Number of Device Deficiencies Per Knee | 0.0 Mean # of DDs per knee |
Secondary
Measure of Knees With Adverse Events
This measure will assess the percentage of knees with reported AEs throughout the duration of the study.
Time frame: Through study completion, up to 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATTUNE Cementless Fixed Bearing | Measure of Knees With Adverse Events | 13.8 % of Knees with AEs |
Secondary
Measure of Knees With Device Deficiencies
This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Population: There were no reported device deficiencies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATTUNE Cementless Fixed Bearing | Measure of Knees With Device Deficiencies | 0.0 % of Knees with Device Deficiencies |
Secondary
One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
One Year Functional Responder Rate All Subjects
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.
Time frame: Through study completion, up to 10 months.
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
One Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
One Year Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
One Year Knee Society Score
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.
Time frame: Through study completion, up to 10 months
Population: 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.
Secondary
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Time frame: Through study completion, up to 6 months
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 12.1 |
| ATTUNE Cementless Fixed Bearing | 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
Six Month Forgotten Joint Score (FJS-12)
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
Time frame: Through study completion, up to 6 months
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | Six Month Forgotten Joint Score (FJS-12) | 49.54 Scores on a scale | Standard Deviation 16.463 |
Secondary
Six Month Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 6 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | Six Month Investigator-conducted Radiographic Analysis | Osteolysis | 2.0 % of Knees with Significant Findings |
| ATTUNE Cementless Fixed Bearing | Six Month Investigator-conducted Radiographic Analysis | Radiolucency | 2.0 % of Knees with Significant Findings |
Secondary
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Through study completion, up to 6 Months
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
Secondary
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Time frame: Through study completion, up to 6 weeks
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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
Six Week Forgotten Joint Score (FJS-12)
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
Time frame: Through study completion, up to 6 weeks
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | Six Week Forgotten Joint Score (FJS-12) | 20.07 Scores on a scale | Standard Deviation 17.701 |
Secondary
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Through study completion, up to 6 weeks
Population: Analysis not completed due to early closure of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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 |
| ATTUNE Cementless Fixed Bearing | 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
Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Two Year Forgotten Joint Score (FJS-12)
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
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Two Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Two Year Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Through study completion, up to 10 months
Population: Data were not collected as the study terminated prior to the pre-specified analysis timepoint.
Secondary
Two Year Knee Society Score
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.
Time frame: Through study completion, up to 10 months
Population: 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.