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Participant recruitment difficulties. Ruling to terminate study made Oct 2019
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A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Other | Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako |
|
| Total Knee Replacement (TKR) | Other | Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker Triathlon Primary Total Knee System | Device | Total Knee Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score | Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome. | pre-op, 6 weeks, 3 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life EQ-5D | Comparing functional and clinical outcomes using the EQ-5D. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. Index values range from 0-1, with 1 being representing "full health". The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. The VAS scales represents health on the day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gavin Clark, Dr | Perth Hip and Knee and St John of God Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth Hip & Knee | Subiaco | Western Australia | 6008 | Australia |
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In addition to the 8 Bicompartmental and 9 Total Knee replacement patients, 1 patient in the study was not randomised prior to surgery.
Upon being assessed against the inclusion and exclusion criteria, suitable patients were randomised to one arm of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bicompartmental Knee Replacement (BKR) | Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement |
| FG001 | Total Knee Replacement (TKR) | Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
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| ID | Title | Description |
|---|---|---|
| BG000 | Bicompartmental Knee Replacement (BKR) | Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome. | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | units on a scale | pre-op, 6 weeks, 3 months, 12 months, 24 months |
|
2 years post-operation
1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
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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 | Bicompartmental Knee Replacement (BKR) | Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contralateral knee osteoarthirits | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | (operative side) |
There existed complexities in recruiting patients that complied with the inclusion and exclusion criteria of the study. The randomised nature of this study required detailed criteria, yet it was difficult in recruiting patients suitable for both bicompartmental and total knee replacement surgeries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alissa Connelly | Stryker | +61294671000 | 1075 | alissa.connelly@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Oct 12, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patients receiving CT but NO Arthrogram | Feb 22, 2018 | Oct 12, 2020 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patients receiving CT WITH Arthrogram | Feb 22, 2018 | Oct 12, 2020 | ICF_002.pdf |
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| Restoris MCK Multicompartmental Knee System | Device | Bicompartmental Knee Replacement |
|
| 24 months/ 2years |
| VAS Pain | Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain. | 24 months/ 2years |
| New Knee Society Score (KSS) | Comparing functional and clinical outcomes using the KSS. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | 24 months/ 2years |
| Forgotten Joint Score (FJS) | Comparing functional and clinical outcomes using the FJS. The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life). | 24 months/ 2years |
| Incidence of Loosening, Reoperation and Revision | To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports. | 6 weeks, 3 months, 12 months, 24 months |
| Length of Hospital Stay | To compare length of hospital stay between the two arms of the study | 6 weeks |
| Total Knee Replacement (TKR) |
Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Total Knee Replacement (TKR) | Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement |
|
|
|
| Secondary | Health Related Quality of Life EQ-5D | Comparing functional and clinical outcomes using the EQ-5D. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. Index values range from 0-1, with 1 being representing "full health". The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. The VAS scales represents health on the day. | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | units on a scale | 24 months/ 2years |
|
|
|
|
| Secondary | VAS Pain | Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain. | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | units on a scale | 24 months/ 2years |
|
|
|
|
| Secondary | New Knee Society Score (KSS) | Comparing functional and clinical outcomes using the KSS. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | units on a scale | 24 months/ 2years |
|
|
|
|
| Secondary | Forgotten Joint Score (FJS) | Comparing functional and clinical outcomes using the FJS. The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life). | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | units on a scale | 24 months/ 2years |
|
|
|
|
| Secondary | Incidence of Loosening, Reoperation and Revision | To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports. | Image quality not obtained to perform incidence calculations thus the incidence of loosening, reoperation and revision detailed below are solely based off the Serious Adverse Events and Adverse Events reported. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Count of Participants | Participants | 6 weeks, 3 months, 12 months, 24 months |
|
|
|
| Secondary | Length of Hospital Stay | To compare length of hospital stay between the two arms of the study | The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8). | Posted | Mean | Standard Deviation | Number of nights | 6 weeks |
|
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| 1 |
| 8 |
| EG001 | Total Knee Replacement (TKR) | Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement | 0 | 8 | 0 | 8 | 2 | 8 |
| Contralateral knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Contralateral Bicompartmental Knee Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Internal Cardiac Defibrillator implanted | Cardiac disorders | Non-systematic Assessment |
|
|
| Lateral knee pain and anterior fat pad impingement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | (operative side) |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | (operative side) |
|
| Sinus and ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
Since the study has been discontinued due to the sample size not being reached, the data cannot be analysed and there are no trial results to discuss/ publish.
| Pre-op EQ-5D VAS |
|
|
| 3-month EQ-5D Index |
|
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| 3-month EQ-5D VAS |
|
|
| 12-month EQ-5D Index |
|
|
| 12-month EQ-5D VAS |
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| 24-month EQ-5D Index |
|
|
| 24-month EQ-5D VAS |
|
|
|
To compare EQ-5D index at 3-months between both groups. |
| t-test, 2 sided |
| 0.90 |
The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. |
| Equivalence |
Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare EQ-5D index at 12-months between both groups. | t-test, 2 sided | 0.57 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare EQ-5D index at 24-months between both groups. | t-test, 2 sided | 0.49 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare EQ-5D VAS preoperatively between both groups. | t-test, 2 sided | 0.65 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means |
| To compare EQ-5D VAS at 3-months between both groups. | t-test, 2 sided | 0.30 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare EQ-5D VAS at 12-months between both groups. | t-test, 2 sided | 0.06 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare EQ-5D VAS at 24-months between both groups. | t-test, 2 sided | 0.44 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| Pre-op VAS Pain at mobilization |
|
|
| 3-month VAS Pain at rest |
|
|
| 3-month VAS Pain at mobilization |
|
|
| 12-month VAS Pain at rest |
|
|
| 12-month VAS Pain at mobilization |
|
|
| 24-month VAS Pain at rest |
|
|
| 24-month VAS Pain at mobilization |
|
|
|
To compare VAS Pain at Rest at 3-months between both groups. |
| t-test, 2 sided |
| 0.45 |
The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. |
| Equivalence |
Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Rest at 12-months between both groups. | t-test, 2 sided | 0.64 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Rest at 24-months between both groups. | t-test, 2 sided | 0.19 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Mobilisation preoperatively between both groups. | t-test, 2 sided | 0.57 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Mobilisation at 3-months between both groups. | t-test, 2 sided | 0.98 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Mobilisation at 12-months between both groups. | t-test, 2 sided | 0.58 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare VAS Pain at Mobilisation at 24-months between both groups. | t-test, 2 sided | 0.16 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| KSS function at 3-month |
|
|
| KSS function at 24-month |
|
|
|
To compare New Knee Society Function Score at 3-months between both groups. |
| t-test, 2 sided |
| 0.06 |
The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. |
| Equivalence |
Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare New Knee Society Function Score at 24-months between both groups. | t-test, 2 sided | 0.93 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| FJS 3-month |
|
|
| FJS 12-month |
|
|
| FJS 24-month |
|
|
To compare FJS at 3-months between both groups. |
| t-test, 2 sided |
| 0.17 |
The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. |
| Equivalence |
Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare FJS at 12-months between both groups. | t-test, 2 sided | 0.80 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| To compare FJS at 24-months between both groups. | t-test, 2 sided | 0.90 | The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings. | Equivalence | Equivalence defined as less than or equal to 1 standard deviation between the two means. |
| Incidence of revision |
|