Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Joint feeling and Forgotten Joint Score |
To evaluate differences in joint feeling assessed via the Forgotten Joint Score. This newly-developed 12-item score ranges from 0 to 100 and assesses how aware recipients are of their joint in everyday life. Higher scores indicate a good outcome i.e. a high degree of forgetting the joint. For the purpose of this study a change in score of 14 points for the Forgotten Joint Score has been identified. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months (primary timepoint) and 24 months |
|
| Secondary |
Function and Oxford Knee Score |
To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Oxford Knee Score. This score ranges from 0 to 48 where a higher score indicates a better outcome. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Function and The International Knee Society Score |
To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months |
|
| Secondary |
Function and Knee Injury and Osteoarthritis Outcome Score |
To evaluate differences in function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Pain and Oxford Knee Score |
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Oxford Knee Score. This score ranges from 0 to 48 where a higher score indicates a better outcome. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Pain and The International Knee Society Score |
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: The International Knee Society Score. This score ranges from 0 to 100 where a higher score correlates to a better outcome. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 12 months and 24 months |
|
| Secondary |
Pain and Knee Injury and Osteoarthritis Outcome Score |
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Knee Injury and Osteoarthritis Outcome Score. This score ranges from 0 to 100 where 0 indicates the worst possible knee symptoms and 100 signifies no knee symptoms. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Pain and Visual Analogue Scale |
To evaluate differences in pain between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following graphic measurement instrument: Visual Analogue Scale. This scale is a continuum between no pain and the worst possible pain imaginable. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Satisfaction and Net Promoter Score |
To evaluate differences in satisfaction between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Net Promoter. This score ranges from -100 to 100 where the upper end indicates the patient's recommendation of the healthcare they received. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Health related quality of life and Euro-Qol (EQ-5D-3L) |
To evaluate differences in health-related quality of life between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This will be achieved by employing the following instrument: Euro-Qol (EQ-5D-3L). This score ranges from 0 to 100 where 0 correlates to the worst imaginable health state whilst 100 indicates the best. |
Pre-operative (2 weeks prior to surgery), Post-operative - 6 weeks, 6 months, 12 months and 24 months |
|
| Secondary |
Early pain |
To evaluate differences in early pain (i.e. from in-patient setting to 6-months post operation) between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through the use of a patient pain inventory form. |
In-patient setting (< 5 days post-operation), Post-operative - 6 weeks and 6 months |
|
| Secondary |
Early function |
To evaluate differences in early function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing functional tests conducted by physiotherapists. The following functional test will be carried out on the knee joint: Range of motion |
In-patient setting (< 5 days post-operation) |
|
| Secondary |
Early function |
To evaluate differences in early function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing functional tests conducted by physiotherapists. The following functional test will be employed: 9 step stair climb |
In-patient setting (< 5 days post-operation) |
|
| Secondary |
Early function |
To evaluate differences in early function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing functional tests conducted by physiotherapists. The following functional test will be employed: fast paced 10m walk test |
In-patient setting (< 5 days post-operation) |
|
| Secondary |
Early function |
To evaluate differences in early function between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved by utilizing functional tests conducted by physiotherapists. The following functional test will be employed: 30 second chair stand test |
In-patient setting (< 5 days post-operation) |
|
| Secondary |
Blood loss |
To compare blood loss between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining surgical data. |
Intra-operative |
|
| Secondary |
Adjustments to balance |
To compare adjustments to balance between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This objective will be achieved through obtaining the position from the Robotic system. |
Intra-operative |
|
| Secondary |
Ability to reach target knee balance as assessed by alignment angles and gaps |
To compare the ability to achieve soft tissue balance between Robotic Assisted Functional Alignment and Robotic Assisted Mechanical Alignment. This object will be achieved by comparing pre-operative plan and pre-resection gaps with the final surgical plan and implanted gaps as derived from the robotic system. The implant position is defined as the angulation of components and resected bone in each anatomical plane. The soft tissue balance is defined as gaps created in extension and 90° of flexion when stressing the medial compartment (medial collateral ligament) and lateral compartment (lateral collateral ligament). The overall limb alignment is assessed by comparing the Hip-Knee-Ankle angle from pre-operative to 1-year post-operative on a long leg weight bearing x-ray. |
Pre-operative (2 weeks prior to surgery), intra-operative, Post-operative - 6 weeks, 12 months and 24 months |
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