Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OtisMed® ShapeMatch® with Triathlon | Active Comparator | Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment). |
|
| Stryker Precision Knee Navigation | Active Comparator | Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OtisMed® ShapeMatch® Technology | Device | The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score | To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. 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. | Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) | Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
For all results participants=knees.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OtisMed® ShapeMatch® With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology. |
| FG001 | Stryker Precision Knee Navigation | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
OtisMed Shapematch with Triathlon is the new intervention for component placement in total knee arthroplasty. This will be compared to the current standard (control) of Stryker Precision Knee Navigation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OtisMed® ShapeMatch® With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology. |
| BG001 | Stryker Precision Knee Navigation |
| 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 | To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. 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. | Shapematch: 49 had preoperative,48 had 6 week, 46 had 6 months, 48 had 12 month, 49 had 2 year and 47 had 5 year scores. Navigation: 50 had preoperative, 47 had 6 week, 46 had 6 months, 49 had 12 month, 50 had 2 years and 48 had 5 years scores. Participants=knees | Posted | Mean | Standard Deviation | units on a scale | Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively |
|
5-years
Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular & bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OtisMed® ShapeMatch® With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Fulker | Stryker South Pacific | +61 2 9467 1072 | david.fulker@stryker.com |
Not provided
| 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 | Mar 25, 2014 | Feb 7, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stryker Precision Knee Navigation | Device | Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol. |
|
| Total Knee Replacement | Procedure |
|
| Stryker Triathlon® Total Knee System | Device | Prosthetic components to be implanted including
|
|
| Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
| Cost Effectiveness: Wound Length | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm. | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
| Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data. | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
| Cost Effectiveness: Length of Stay in Hospital | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported.. | 14 days |
| Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores. | 12 months |
| Knee Pain | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories. | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
| Health-related Quality of Life (EQ-5D-3L) | 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. The index can be calculated by deducting the appropriate weights from 1= the value for 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'. | Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years |
| The Forgotten Joint Score (FJS-12) | 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). | 6 week, 6 month, 12 month , 2 years and 5 years visits |
| The International Knee Society Score (IKSS) | 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. | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
| Perth CT Protocol | The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus. | 3 months |
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
| 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 |
|
| OG000 | OtisMed® ShapeMatch® With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology. |
| OG001 | Stryker Precision Knee Navigation | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation. |
|
|
|
| Secondary | Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) | Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time. | Posted | Mean | Standard Deviation | minutes | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
|
|
|
|
| Secondary | Cost Effectiveness: Wound Length | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm. | Posted | Mean | Standard Deviation | millimeters | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
|
|
|
|
| Secondary | Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data. | Cost effectiveness data is not available. | Posted | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
|
|
| Secondary | Cost Effectiveness: Length of Stay in Hospital | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported.. | Posted | Mean | Standard Deviation | days | 14 days |
|
|
|
|
| Secondary | Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores. | Shapematch preoperative N=48, 12 month N=48. Navigation preoperative N=50, 12 month N-49. | Posted | Mean | Standard Deviation | QALY life year | 12 months |
|
|
|
|
| Secondary | Knee Pain | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
|
|
|
|
| Secondary | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories. | Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
|
|
|
|
| Secondary | Health-related Quality of Life (EQ-5D-3L) | 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. The index can be calculated by deducting the appropriate weights from 1= the value for 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'. | Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years |
|
|
|
|
| Secondary | The Forgotten Joint Score (FJS-12) | 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). | Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points. | Posted | Mean | Standard Deviation | score on a scale | 6 week, 6 month, 12 month , 2 years and 5 years visits |
|
|
|
|
| Secondary | The International Knee Society Score (IKSS) | 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. | Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively |
|
|
|
|
| Secondary | Perth CT Protocol | The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus. | Participants=knees | Posted | Mean | Standard Deviation | degrees | 3 months |
|
|
|
|
| 0 |
| 49 |
| 39 |
| 49 |
| 24 |
| 49 |
| EG001 | Stryker Precision Knee Navigation | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation. | 0 | 50 | 38 | 50 | 25 | 50 |
| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative site | General disorders | Non-systematic Assessment |
|
| Non-operative site | Hepatobiliary disorders | Non-systematic Assessment |
|
| Operative site | Infections and infestations | Non-systematic Assessment |
|
| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non-operative site | Psychiatric disorders | Non-systematic Assessment |
|
| Non-operative site | Renal and urinary disorders | Non-systematic Assessment |
|
| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Vascular disorders | Non-systematic Assessment |
|
| Non-operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Non-operative site | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Non-operative site | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Non-operative site | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Non-operative site | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Non-operative site | Endocrine disorders | Non-systematic Assessment |
|
| Non-operative site | Eye disorders | Non-systematic Assessment |
|
| Non-operative site | Immune system disorders | Non-systematic Assessment |
|
| Non-operative site | Infections and infestations | Non-systematic Assessment |
|
| Operative site | Investigations | Non-systematic Assessment |
|
| Non-operative site | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Non-operative side | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative side | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Non-operative side | Product Issues | Non-systematic Assessment |
|
| Non-operative site | Social circumstances | Non-systematic Assessment |
|
| Operative site | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-operative site | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-operative site | Eye disorders | Non-systematic Assessment |
|
| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative site | General disorders | Non-systematic Assessment |
|
| Non-operative site | Infections and infestations | Non-systematic Assessment |
|
| Non-operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative site | Product Issues | Non-systematic Assessment |
|
| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative site | Surgical and medical procedures | Non-systematic Assessment |
|
Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| 12 Month QALY |
|
|
| t-test, 2 sided |
| 0.23 |
| Mean Difference (Final Values) |
| -0.043 |
| 2-Sided |
| Superiority |
| Pre-op Pain at Mobilisation |
|
|
| 6-week Pain at Rest |
|
|
| 6-week Pain at Mobilisation |
|
|
| 6-month Pain at Rest |
|
|
| 6-month Pain at Mobilisation |
|
|
| 1-year Pain at Rest |
|
|
| 1-year Pain at Mobilisation |
|
|
| 2-year Pain at Rest |
|
|
| 2-year Pain at Mobilisation |
|
|
| 5-year Pain at Rest |
|
|
| 5-year Pain at Mobilisation |
|
|
| t-test, 2 sided |
| 0.7545 |
| Equivalence |
To determine equivalence in baseline characteristics between the control and intervention group. |
| To compare VAS rest at 6 weeks between both groups. | t-test, 2 sided | 0.6921 | Non-Inferiority | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS mobilisation at 6 weeks between both groups. | t-test, 2 sided | 0.9601 | Non-Inferiority | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS rest at 6 months between both groups. | t-test, 2 sided | 0.0697 | Non-Inferiority | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS mobilisation at 6 months between both groups. | t-test, 2 sided | 0.0342 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS rest at 12 months between both groups. | t-test, 2 sided | 0.3487 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS mobilisation at 1 year between both groups. | t-test, 2 sided | 0.2201 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS rest at 2 years between both groups. | t-test, 2 sided | 0.2291 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS mobilisation at 2 years between both groups. | t-test, 2 sided | 0.6436 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS rest at 5 years between both groups. | t-test, 2 sided | 0.4344 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| To compare VAS mobilisation at 5 years between both groups. | t-test, 2 sided | 0.8732 | Equivalence | Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon |
| 6-week |
|
|
| 6-month |
|
|
| 1-year |
|
|
| 2-year |
|
|
| 5-year |
|
|
| 0.588 |
| Superiority |
| To compare WOMAC at 6-months between both groups. | t-test, 2 sided | 0.030 | Superiority |
| To compare WOMAC at 1-year between both groups. | t-test, 2 sided | 0.131 | Superiority |
| To compare WOMAC at 2-years between both groups. | t-test, 2 sided | 0.347 | Superiority |
| To compare WOMAC at 5-years between both groups. | t-test, 2 sided | 0.341 | Superiority |
| Pre-op EQ-5D VAS |
|
|
| 6-week EQ-5D Index |
|
|
| 6-week EQ-5D VAS |
|
|
| 6-month EQ-5D Index |
|
|
| 6-month EQ-5D VAS |
|
|
| 1-year EQ-5D Index |
|
|
| 1-year EQ-5D VAS |
|
|
| 2-year EQ-5D Index |
|
|
| 2-year EQ-5D VAS |
|
|
| 5-year EQ-5D Index |
|
|
| 5-year EQ-5D VAS |
|
|
| 0.201 |
| Superiority |
| To compare EQ-5D index at 6-weeks between both groups. | t-test, 2 sided | 0.741 | Superiority |
| To compare EQ-5D VAS at 6-weeks between both groups. | t-test, 2 sided | 0.794 | Superiority |
| To compare EQ-5D index at 6-months between both groups. | t-test, 2 sided | 0.232 | Superiority |
| To compare EQ-5D VAS at 6-months between both groups. | t-test, 2 sided | 0.513 | Superiority |
| To compare EQ-5D index at 1-year between both groups. | t-test, 2 sided | 0.180 | Superiority |
| To compare EQ-5D VAS at 1-year between both groups. | t-test, 2 sided | 0.864 | Superiority |
| To compare EQ-5D index at 2-year between both groups. | t-test, 2 sided | 0.223 | Superiority |
| To compare EQ-5D VAS at 2-year between both groups. | t-test, 2 sided | 0.355 | Superiority |
| To compare EQ-5D index at 5-year between both groups. | t-test, 2 sided | 0.314 | Superiority |
| To compare EQ-5D VAS at 5-year between both groups. | t-test, 2 sided | 0.914 | Superiority |
| 6 month |
|
|
| 12 month |
|
|
| 2 year |
|
|
| 5 year |
|
|
| 0.932 |
| Superiority |
| To compare FJS at 1-year between both groups. | t-test, 2 sided | 0.934 | Superiority |
| To compare FJS at 2-year between both groups. | t-test, 2 sided | 0.566 | Superiority |
| To compare FJS at 5-year between both groups. | t-test, 2 sided | 0.263 | Superiority |
| Pre-op IKSS Function |
|
|
| Pre-op Range of Motion |
|
|
| 6 week IKSS Pain |
|
|
| 6 week IKSS Function |
|
|
| 6 week Range of Motion |
|
|
| 6 month IKSS Pain |
|
|
| 6 month IKSS Function |
|
|
| 6 month Range of Motion |
|
|
| 12 month IKSS Pain |
|
|
| 12 month IKSS Function |
|
|
| 12 month Range of Motion |
|
|
| 2 year IKSS Pain |
|
|
| 2 year IKSS Function |
|
|
| 2 year Range of Motion |
|
|
| 5 year IKSS Pain |
|
|
| 5 year IKSS Function |
|
|
| 5 year Range of Motion |
|
|
| 0.6425 |
| Superiority |
| To compare IKSS ROM preoperatively between both groups. | t-test, 2 sided | 0.5041 | Superiority |
| To compare IKSS Pain at 6-weeks between both groups. | t-test, 2 sided | 0.2230 | Superiority |
| To compare IKSS Function at 6-weeks between both groups. | t-test, 2 sided | 0.8209 | Superiority |
| To compare IKSS ROM at 6-weeks between both groups. | t-test, 2 sided | 0.6958 | Superiority |
| To compare IKSS Pain at 6-months between both groups. | t-test, 2 sided | 0.0548 | Superiority |
| To compare IKSS Function at 6-months between both groups. | t-test, 2 sided | 0.1958 | Superiority |
| To compare IKSS ROM at 6-months between both groups. | t-test, 2 sided | 0.2786 | Superiority |
| To compare IKSS Pain at 1-year between both groups. | t-test, 2 sided | 0.2399 | Superiority |
| To compare IKSS Function at 1-year between both groups. | t-test, 2 sided | 0.4135 | Superiority |
| To compare IKSS ROM at 1-year between both groups. | t-test, 2 sided | 0.5278 | Superiority |
| To compare IKSS Pain at 2-year between both groups. | t-test, 2 sided | 0.2992 | Superiority |
| To compare IKSS Function at 2-year between both groups. | t-test, 2 sided | 0.5462 | Superiority |
| To compare IKSS ROM at 2-year between both groups. | t-test, 2 sided | 0.5765 | Superiority |
| To compare IKSS Pain at 5-year between both groups. | t-test, 2 sided | 0.5493 | Superiority |
| To compare IKSS Function at 5-year between both groups. | t-test, 2 sided | 0.1705 | Superiority |
| To compare IKSS ROM at 5-year between both groups. | t-test, 2 sided | 0.2918 | Superiority |
| Coronal angle tibial comp and mech axis tibia |
|
| Sagital tibial component slope |
|
| Femcomp rotationrelative to surg epicond axis+=ER |
|
| 0.002 |
| Other |
| Comparison of coronal angle tibial comp and mech axis tibia between both groups. | t-test, 2 sided | <0.001 | Other |
| Comparison of sagital tibial component slope between both groups. | t-test, 2 sided | <0.001 | Other |
| Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups. | t-test, 2 sided | <0.001 | Other |