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It was terminated by sponsor for updated evidence needs
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Background:
The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM)
Purpose:
Post-market evidence generation for JOURNEY II CR Total Knee System
Objectives:
Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA
Research participants / locations:
A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resurfaced/non patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System |
| |
| un-resurfaced patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resurfaced Patella | Device | JOURNEY II CR Total Knee System was used for Total Knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (OKS) at 2 Years | The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Forgotten Joint Score (FJS) | The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. This questionnaire focuses on the study participant's awareness of the partially or fully replaced knee joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.
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| Name | Affiliation | Role |
|---|---|---|
| Julian Yang | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100083 | China | |||
| Prince of Wales Hospital |
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There were 62 participants in total enrolled into the study across 5 study sites. The 60 participants that received the study device were included in the analysis. Two participants were excluded before assignment to groups because they did not receive the study device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resurfaced/Non Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
| FG001 | Un-resurfaced Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Resurfaced/Non Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
| BG001 | Un-resurfaced Patella |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxford Knee Score (OKS) at 2 Years | The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome. | Data not collected for outcome because no participant reached the 2 year time frame due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for this visit. | Posted | 2 years |
|
Adverse events were collected from surgery to study termination, approximately 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resurfaced/Non Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OSTEOARTHRITIS IN THE CARPOMETACARPAL JOINT OF THE RIGHT THUMB | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEVER | General disorders | Systematic Assessment | Not related to device or procedure |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | +44 7811 407089 | datasharing.gcs@smith-nephew.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2021 | Mar 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2024 | Mar 31, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Un-resurfaced Patella | Procedure | JOURNEY II CR Total Knee System was used for Total Knee replacement |
|
| 6 months, 1 year, 2 years, 3 years |
| Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a Patient Reported Outcome (PRO) questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Overall scores range from 0 to 48, where a score of 0 is the worst possible outcome and a score of 48 is the best possible outcome. | Pre-Operative, 6 months, 1 year, 3 years |
| Knee Society Score (KSS): "Objective" Knee Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales: The "Objective" Knee Score sub-scale is assessed by the surgeon, focusing on clinical measures such as pain, range of motion, and stability. The score is 7 items on a scale of 0 to 100 where a higher score indicates a better outcome. | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
| Knee Society Score (KSS): Patient Satisfaction Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Satisfaction sub-scale score evaluates the participant's satisfaction with their knee function and pain relief. The score is five items on a scale of 0 to 40 where a higher score indicates a better outcome. | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
| Knee Society Score (KSS): Patient Expectation Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Expectation sub-scale score assesses the participant's expectations regarding their knee function and outcomes. The score is three items on a scale of 3 to 15 where a higher score indicates a better outcome. | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
| Knee Society Score (KSS): Functional Knee Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities to evaluate the participant's ability to perform daily activities and their overall functional capabilities. The score is 19 items on a scale of 0 to 100 where a higher score indicates a better outcome. | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
| Patient Expectation | Patient expectation measured by asking participants to select "ONE activity that matters to you most and you expect to participate after the surgery?" Responses were categorized as:
| Pre-Operative |
| Patient Satisfaction | Patient satisfaction is measured by a corresponding question based on their expectation asking, "How satisfied are you with the surgery meeting your expectation?" Responses were categorized as:
| 6 months, 1 year, 2 years, 3 years |
| Radiographic Assessment: Presence of Radiographic Findings | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the number of participants with the presence of radiographic findings categorized as:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Aseptic Loosening | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of aseptic loosening as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Septic Loosening | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of septic loosening as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Bone Fracture | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of bone fracture as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Cement Fracture | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of cement fracture as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Osteolysis | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of osteolysis as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Subsidence | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of subsidence as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Implant Migration | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant migration as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Stress Shielding | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of stress shielding as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Implant-Cement Debonding | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant-cement debonding as one of the following:
| Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
| Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to determine mechanical axis alignment of the knee joint in degrees measured through the centre of the hip (centre of the spherical femoral head), centre of the knee (centre of the tibial plateau) and centre of the ankle (centre of the talus). | Pre-Operative, 6 months, 1 year, 2 years |
| Hong Kong |
| China |
| Aster RV Hospital, Bangalore | Bengaluru | Karnataka | 560078 | India |
| Arcus Hospital | Pune | Maharashtra | 411040 | India |
| Toho University Omori Medical Center | Tokyo | 1438540 | Japan |
| Tokyo Women's Medical University | Tokyo | 1628666 | Japan |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Site Terminated by Sponsor |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Operative Diagnosis | Count of Participants | Participants |
|
| Resurfaced/Non Patella |
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
| OG001 | Un-resurfaced Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement |
|
| Secondary | Forgotten Joint Score (FJS) | The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. This questionnaire focuses on the study participant's awareness of the partially or fully replaced knee joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome). | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a Patient Reported Outcome (PRO) questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Overall scores range from 0 to 48, where a score of 0 is the worst possible outcome and a score of 48 is the best possible outcome. | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 months, 1 year, 3 years |
|
|
|
| Secondary | Knee Society Score (KSS): "Objective" Knee Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales: The "Objective" Knee Score sub-scale is assessed by the surgeon, focusing on clinical measures such as pain, range of motion, and stability. The score is 7 items on a scale of 0 to 100 where a higher score indicates a better outcome. | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Knee Society Score (KSS): Patient Satisfaction Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Satisfaction sub-scale score evaluates the participant's satisfaction with their knee function and pain relief. The score is five items on a scale of 0 to 40 where a higher score indicates a better outcome. | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Knee Society Score (KSS): Patient Expectation Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Expectation sub-scale score assesses the participant's expectations regarding their knee function and outcomes. The score is three items on a scale of 3 to 15 where a higher score indicates a better outcome. | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Knee Society Score (KSS): Functional Knee Score | The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities to evaluate the participant's ability to perform daily activities and their overall functional capabilities. The score is 19 items on a scale of 0 to 100 where a higher score indicates a better outcome. | Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operative, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Patient Expectation | Patient expectation measured by asking participants to select "ONE activity that matters to you most and you expect to participate after the surgery?" Responses were categorized as:
| Participants that received the study device with data collected for the outcome and time frame indicated. | Posted | Count of Participants | Participants | Pre-Operative |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction is measured by a corresponding question based on their expectation asking, "How satisfied are you with the surgery meeting your expectation?" Responses were categorized as:
| Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Count of Participants | Participants | 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Radiographic Assessment: Presence of Radiographic Findings | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the number of participants with the presence of radiographic findings categorized as:
| Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Aseptic Loosening | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of aseptic loosening as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for Aseptic Loosening radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Septic Loosening | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of septic loosening as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Septic Loosening radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Bone Fracture | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of bone fracture as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Bone Fracture radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Cement Fracture | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of cement fracture as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Cement Fracture radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Osteolysis | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of osteolysis as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Osteolysis radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Subsidence | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of subsidence as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Subsidence radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Implant Migration | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant migration as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Implant Migration radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Stress Shielding | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of stress shielding as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Stress Shielding radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Implant-Cement Debonding | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant-cement debonding as one of the following:
| Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Implant-Cement Debonding radiographic finding option. | Posted | Count of Participants | Participants | Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint | Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to determine mechanical axis alignment of the knee joint in degrees measured through the centre of the hip (centre of the spherical femoral head), centre of the knee (centre of the tibial plateau) and centre of the ankle (centre of the talus). | While general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. Additionally, 0 participants were analyzed at 1 year for mechanical axis alignment because data was not provided by the third party central imaging lab due to contract suspension and later study termination, so data after 6 months cannot be reported. | Posted | Mean | Standard Deviation | degrees | Pre-Operative, 6 months, 1 year, 2 years |
|
|
|
| 0 |
| 44 |
| 5 |
| 44 |
| 20 |
| 44 |
| EG001 | Un-resurfaced Patella | Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement | 0 | 16 | 2 | 16 | 1 | 16 |
|
| ACUTE GALLBLADDER INFLAMMATION | Hepatobiliary disorders | Systematic Assessment | Not related to device or procedure |
|
| LOCALIZED PROSTATE CANCER | Reproductive system and breast disorders | Systematic Assessment | Not related to device or procedure |
|
| STERNUM FRACTURE | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| LEFT BREAST CANCER | Reproductive system and breast disorders | Systematic Assessment | Not related to device or procedure |
|
| LEFT KNEE OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| PAIN AND SWELLING DYSFUNCTION AFTER RIGHT KNEE REPLACEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device but related to procedure |
|
| PAIN AFTER RIGHT KNEE REPLACEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| UTERINE MYOMA | Reproductive system and breast disorders | Systematic Assessment | Not related to device or procedure |
|
| ILIOTIBIAL BAND SYNDROME OF RIGHT LEG | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| NUMBNESS IN RIGHT TOES | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| RIGHT OTITIS MEDIA WITH EFFUSION | Ear and labyrinth disorders | Systematic Assessment | Not related to device or procedure |
|
| ORAL CANDIDIASIS | Infections and infestations | Systematic Assessment | Not related to device or procedure |
|
| DIZZINESS | General disorders | Systematic Assessment | Not related to device or procedure |
|
| LEFT COXODYNIA | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| PRIMARY HAND ARTHROPATHY OF RIGHT HAND | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| PERIPHERAL NEUROPATHY | Nervous system disorders | Systematic Assessment | Not related to device or procedure |
|
| MENIERE'S DISEASE | Ear and labyrinth disorders | Systematic Assessment | Not related to device or procedure |
|
| LEFT LUMBALGIA | General disorders | Systematic Assessment | Not related to device or procedure |
|
| TRANSIENT LOSS OF CONSCIOUSNESS | General disorders | Systematic Assessment | Not related to device or procedure |
|
| SEBORRHEIC DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| UPPER AND LOWER EXTREMITY ERUPTION | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment | Not related to device or procedure |
|
| CYSTITIS | Renal and urinary disorders | Systematic Assessment | Not related to device or procedure |
|
| RIGHT ANKLE SPRAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| REFLUX ESOPHAGITIS | Gastrointestinal disorders | Systematic Assessment | Not related to device or procedure |
|
| ECZEMA | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | Systematic Assessment | Not related to device or procedure |
|
| BOTH LOWER EXTREMITY ERUPTION | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| TINNITUS | Ear and labyrinth disorders | Systematic Assessment | Not related to device or procedure |
|
| LEFT LOWER LEG CRAMPS IN THE CALVES | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| LUMBAR PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| MALAISE | Psychiatric disorders | Systematic Assessment | Not related to device or procedure |
|
| SCIATICA | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to device or procedure |
|
| GASTRALGIA | Gastrointestinal disorders | Systematic Assessment | Not related to device or procedure |
|
| DIZZINESS | General disorders | Systematic Assessment | Not related to device or procedure |
|
| TREMORS | Nervous system disorders | Systematic Assessment | Not related to device or procedure |
|
Not provided
Not provided
| 1 year |
|
|
| 2 years |
|
| 3 years |
|
| 6 months |
|
|
| 1 year |
|
|
| 3 years |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
| 3 years |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
| 3 years |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
| 3 years |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
| 3 years |
|
| Regularly participate in very active events |
|
| Regularly participate in active events |
|
| Regularly participate in moderate activities |
|
| Sometimes participate in moderate activities |
|
| Regularly participate in mild activities |
|
| Sometimes participate in mild activities |
|
| Restricted to minimal activities of daily living |
|
| Missing |
|
| Satisfied |
|
| Neutral |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Missing |
|
| 1 year |
|
|
| 2 years |
|
|
| 3 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| Missing |
|
| 6 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| 6 months |
|
|
| 1 year |
|
| 2 years |
|