Non-inflammatory Degenerative Joint Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStryker Triathlon Primary Total Knee System
Total Knee Replacement
DEVICERestoris MCK Multicompartmental Knee System
Bicompartmental Knee Replacement
Sponsors
Stryker South Pacific
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion) 2. The patient has no fixed flexion greater than 10 degrees. 3. The patient has maximal flexion greater than 100 degrees 4. The patient has a passively correctable varus deformity 5. The patient has a functionally Intact Anterior Cruciate Ligament (ACL.) 6. The patient has no significant patellofemoral malalignment 7. The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion). 8. The patient has pain that is not localised to the medial compartment only 9. The patient is a male or non-pregnant female. 10. The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion criteria
1. The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram. 2. The patient is undergoing revision surgery 3. The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture 4. The patient has active, local infection or previous intra-articular infection 5. The patient has skeletal immaturity 6. The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis 7. The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion). 8. The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed. 9. Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it 10. Patients with tricompartmental disease are contraindicated from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | pre-op, 6 weeks, 3 months, 12 months, 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain | 24 months/ 2years | 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. |
| New Knee Society Score (KSS) | 24 months/ 2years | 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. |
| Health Related Quality of Life EQ-5D | 24 months/ 2years | 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. |
| Incidence of Loosening, Reoperation and Revision | 6 weeks, 3 months, 12 months, 24 months | 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. |
| Length of Hospital Stay | 6 weeks | To compare length of hospital stay between the two arms of the study |
| Forgotten Joint Score (FJS) | 24 months/ 2years | 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). |
Countries
Australia
Participant flow
Recruitment details
Upon being assessed against the inclusion and exclusion criteria, suitable patients were randomised to one arm of the study.
Pre-assignment details
In addition to the 8 Bicompartmental and 9 Total Knee replacement patients, 1 patient in the study was not randomised prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent incorrectly taken | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Total Knee Replacement (TKR) | Total | Bicompartmental Knee Replacement (BKR) |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 4.85 | 65 years STANDARD_DEVIATION 4.72 | 65.0 years STANDARD_DEVIATION 4.56 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Australia | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 2 / 8 |
| serious Total, serious adverse events | 3 / 8 | 0 / 8 |
Outcome results
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.
Time frame: pre-op, 6 weeks, 3 months, 12 months, 24 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Oxford Knee Score | Oxford pre-operative | 22.63 units on a scale | Standard Deviation 8.14 |
| Bicompartmental Knee Replacement (BKR) | Oxford Knee Score | Oxford 12-months | 40.43 units on a scale | Standard Deviation 4.17 |
| Bicompartmental Knee Replacement (BKR) | Oxford Knee Score | Oxford 3-months | 39.00 units on a scale | Standard Deviation 3.61 |
| Bicompartmental Knee Replacement (BKR) | Oxford Knee Score | Oxford 24-months | 41.20 units on a scale | Standard Deviation 5.49 |
| Bicompartmental Knee Replacement (BKR) | Oxford Knee Score | Oxford 6-weeks | 34.00 units on a scale | Standard Deviation 6.69 |
| Total Knee Replacement (TKR) | Oxford Knee Score | Oxford 24-months | 43.75 units on a scale | Standard Deviation 3.34 |
| Total Knee Replacement (TKR) | Oxford Knee Score | Oxford pre-operative | 26.75 units on a scale | Standard Deviation 8.9 |
| Total Knee Replacement (TKR) | Oxford Knee Score | Oxford 3-months | 33.29 units on a scale | Standard Deviation 7.63 |
| Total Knee Replacement (TKR) | Oxford Knee Score | Oxford 12-months | 40.33 units on a scale | Standard Deviation 7.95 |
| Total Knee Replacement (TKR) | Oxford Knee Score | Oxford 6-weeks | 30.14 units on a scale | Standard Deviation 3.8 |
Comparison: Comparison between groups at 3-month timepoint.p-value: 0.1t-test, 2 sided
Comparison: Comparison between groups at 12-month timepoint.p-value: 0.98t-test, 2 sided
Comparison: Comparison between groups at 24-month timepoint.p-value: 0.5t-test, 2 sided
Comparison: Comparison between groups at pre-operation timepoint.p-value: 0.46t-test, 2 sided
Comparison: Comparison between groups at 6-week timepoint.p-value: 0.23t-test, 2 sided
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).
Time frame: 24 months/ 2years
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Forgotten Joint Score (FJS) | FJS pre-operative | 11.60 units on a scale | Standard Deviation 3.56 |
| Bicompartmental Knee Replacement (BKR) | Forgotten Joint Score (FJS) | FJS 3-month | 51.30 units on a scale | Standard Deviation 25.92 |
| Bicompartmental Knee Replacement (BKR) | Forgotten Joint Score (FJS) | FJS 12-month | 58.63 units on a scale | Standard Deviation 27.04 |
| Bicompartmental Knee Replacement (BKR) | Forgotten Joint Score (FJS) | FJS 24-month | 64.58 units on a scale | Standard Deviation 23.46 |
| Total Knee Replacement (TKR) | Forgotten Joint Score (FJS) | FJS 24-month | 66.67 units on a scale | Standard Deviation 19.6 |
| Total Knee Replacement (TKR) | Forgotten Joint Score (FJS) | FJS pre-operative | 13.75 units on a scale | Standard Deviation 5.53 |
| Total Knee Replacement (TKR) | Forgotten Joint Score (FJS) | FJS 12-month | 63.19 units on a scale | Standard Deviation 32.4 |
| Total Knee Replacement (TKR) | Forgotten Joint Score (FJS) | FJS 3-month | 30.36 units on a scale | Standard Deviation 25.41 |
Comparison: Comparison between groups at pre-operation timepoint.p-value: 0.57t-test, 2 sided
Comparison: To compare FJS at 3-months between both groups.p-value: 0.17t-test, 2 sided
Comparison: To compare FJS at 12-months between both groups.p-value: 0.8t-test, 2 sided
Comparison: To compare FJS at 24-months between both groups.p-value: 0.9t-test, 2 sided
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.
Time frame: 24 months/ 2years
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 12-month EQ-5D Index | 0.48 units on a scale | Standard Deviation 0.41 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 3-month EQ-5D Index | 0.69 units on a scale | Standard Deviation 0.35 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 12-month EQ-5D VAS | 74.50 units on a scale | Standard Deviation 10.13 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | Pre-op EQ-5D VAS | 78.50 units on a scale | Standard Deviation 12.22 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 24-month EQ-5D Index | 0.63 units on a scale | Standard Deviation 0.62 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 3-month EQ-5D VAS | 82.25 units on a scale | Standard Deviation 12.67 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | 24-month EQ-5D VAS | 80.40 units on a scale | Standard Deviation 11.36 |
| Bicompartmental Knee Replacement (BKR) | Health Related Quality of Life EQ-5D | Pre-op EQ-5D Index | 0.16 units on a scale | Standard Deviation 0.45 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 24-month EQ-5D VAS | 87.25 units on a scale | Standard Deviation 10.62 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | Pre-op EQ-5D VAS | 81.50 units on a scale | Standard Deviation 12.21 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 3-month EQ-5D Index | 0.66 units on a scale | Standard Deviation 0.31 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 3-month EQ-5D VAS | 90.00 units on a scale | Standard Deviation 13.35 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 12-month EQ-5D Index | 0.65 units on a scale | Standard Deviation 0.45 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 12-month EQ-5D VAS | 89.20 units on a scale | Standard Deviation 10.23 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | 24-month EQ-5D Index | 0.89 units on a scale | Standard Deviation 0.13 |
| Total Knee Replacement (TKR) | Health Related Quality of Life EQ-5D | Pre-op EQ-5D Index | 0.28 units on a scale | Standard Deviation 0.4 |
Comparison: To compare EQ-5D Index preoperatively between both groups.p-value: 0.59t-test, 2 sided
Comparison: To compare EQ-5D index at 3-months between both groups.p-value: 0.9t-test, 2 sided
Comparison: To compare EQ-5D index at 12-months between both groups.p-value: 0.57t-test, 2 sided
Comparison: To compare EQ-5D index at 24-months between both groups.p-value: 0.49t-test, 2 sided
Comparison: To compare EQ-5D VAS preoperatively between both groups.p-value: 0.65t-test, 2 sided
Comparison: To compare EQ-5D VAS at 3-months between both groups.p-value: 0.3t-test, 2 sided
Comparison: To compare EQ-5D VAS at 12-months between both groups.p-value: 0.06t-test, 2 sided
Comparison: To compare EQ-5D VAS at 24-months between both groups.p-value: 0.44t-test, 2 sided
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.
Time frame: 6 weeks, 3 months, 12 months, 24 months
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Incidence of Loosening, Reoperation and Revision | Incidence of loosening | 0 Participants |
| Bicompartmental Knee Replacement (BKR) | Incidence of Loosening, Reoperation and Revision | Incidence of reoperation | 0 Participants |
| Bicompartmental Knee Replacement (BKR) | Incidence of Loosening, Reoperation and Revision | Incidence of revision | 0 Participants |
| Total Knee Replacement (TKR) | Incidence of Loosening, Reoperation and Revision | Incidence of loosening | 0 Participants |
| Total Knee Replacement (TKR) | Incidence of Loosening, Reoperation and Revision | Incidence of reoperation | 0 Participants |
| Total Knee Replacement (TKR) | Incidence of Loosening, Reoperation and Revision | Incidence of revision | 0 Participants |
Secondary
Length of Hospital Stay
To compare length of hospital stay between the two arms of the study
Time frame: 6 weeks
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | Length of Hospital Stay | 3 Number of nights | Standard Deviation 1.32 |
| Total Knee Replacement (TKR) | Length of Hospital Stay | 2.86 Number of nights | Standard Deviation 0.64 |
Comparison: To compare length of hospital stay (number of nights) between both groups.p-value: 0.81t-test, 2 sided
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.
Time frame: 24 months/ 2years
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | New Knee Society Score (KSS) | KSS function at pre-operation | 44.29 units on a scale | Standard Deviation 9.65 |
| Bicompartmental Knee Replacement (BKR) | New Knee Society Score (KSS) | KSS function at 3-month | 76.44 units on a scale | Standard Deviation 12.08 |
| Bicompartmental Knee Replacement (BKR) | New Knee Society Score (KSS) | KSS function at 24-month | 84.50 units on a scale | Standard Deviation 9.39 |
| Total Knee Replacement (TKR) | New Knee Society Score (KSS) | KSS function at pre-operation | 48.00 units on a scale | Standard Deviation 15.59 |
| Total Knee Replacement (TKR) | New Knee Society Score (KSS) | KSS function at 3-month | 61.00 units on a scale | Standard Deviation 15.34 |
| Total Knee Replacement (TKR) | New Knee Society Score (KSS) | KSS function at 24-month | 85.33 units on a scale | Standard Deviation 10.4 |
Comparison: To compare New Knee Society Function Score preoperatively between both groups.p-value: 0.62t-test, 2 sided
Comparison: To compare New Knee Society Function Score at 3-months between both groups.p-value: 0.06t-test, 2 sided
Comparison: To compare New Knee Society Function Score at 24-months between both groups.p-value: 0.93t-test, 2 sided
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.
Time frame: 24 months/ 2years
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bicompartmental Knee Replacement (BKR) | VAS Pain | Pre-op VAS Pain at rest | 36.63 units on a scale | Standard Deviation 26.89 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 12-month VAS Pain at rest | 10.40 units on a scale | Standard Deviation 9.41 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 3-month VAS Pain at rest | 12.00 units on a scale | Standard Deviation 17.45 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 12-month VAS Pain at mobilization | 13.60 units on a scale | Standard Deviation 9.65 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | Pre-op VAS Pain at mobilization | 65.00 units on a scale | Standard Deviation 25.63 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 24-month VAS Pain at rest | 0.67 units on a scale | Standard Deviation 0.47 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 3-month VAS Pain at mobilization | 23.67 units on a scale | Standard Deviation 29.44 |
| Bicompartmental Knee Replacement (BKR) | VAS Pain | 24-month VAS Pain at mobilization | 2.33 units on a scale | Standard Deviation 1.7 |
| Total Knee Replacement (TKR) | VAS Pain | 3-month VAS Pain at mobilization | 24.25 units on a scale | Standard Deviation 16.41 |
| Total Knee Replacement (TKR) | VAS Pain | Pre-op VAS Pain at rest | 36.14 units on a scale | Standard Deviation 21.91 |
| Total Knee Replacement (TKR) | VAS Pain | Pre-op VAS Pain at mobilization | 56.86 units on a scale | Standard Deviation 25.18 |
| Total Knee Replacement (TKR) | VAS Pain | 3-month VAS Pain at rest | 22.25 units on a scale | Standard Deviation 18.46 |
| Total Knee Replacement (TKR) | VAS Pain | 24-month VAS Pain at mobilization | 7.75 units on a scale | Standard Deviation 4.6 |
| Total Knee Replacement (TKR) | VAS Pain | 12-month VAS Pain at rest | 19.00 units on a scale | Standard Deviation 32.91 |
| Total Knee Replacement (TKR) | VAS Pain | 12-month VAS Pain at mobilization | 24.25 units on a scale | Standard Deviation 34.4 |
| Total Knee Replacement (TKR) | VAS Pain | 24-month VAS Pain at rest | 3.50 units on a scale | Standard Deviation 2.69 |
Comparison: To compare VAS Pain at Rest preoperatively between both groups.p-value: 0.97t-test, 2 sided
Comparison: To compare VAS Pain at Rest at 3-months between both groups.p-value: 0.45t-test, 2 sided
Comparison: To compare VAS Pain at Rest at 12-months between both groups.p-value: 0.64t-test, 2 sided
Comparison: To compare VAS Pain at Rest at 24-months between both groups.p-value: 0.19t-test, 2 sided
Comparison: To compare VAS Pain at Mobilisation preoperatively between both groups.p-value: 0.57t-test, 2 sided
Comparison: To compare VAS Pain at Mobilisation at 3-months between both groups.p-value: 0.98t-test, 2 sided
Comparison: To compare VAS Pain at Mobilisation at 12-months between both groups.p-value: 0.58t-test, 2 sided
Comparison: To compare VAS Pain at Mobilisation at 24-months between both groups.p-value: 0.16t-test, 2 sided