Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Phase 1 - To assess the safety of the TOKA device by determining the incidence/rate of Adverse Events, Adverse Device Effects, Serious Adverse Device Effects, Serious Adverse Events, Unexpected Serious Adverse Device Effects and complications. |
Incidence/rate of safety events - Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs), Unexpected Serious Adverse Device Effects (SADEs) and complications. |
6 weeks post-surgery |
|
| Primary |
Phase 2 - To establish if digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery. |
The absolute difference between planned and achieved coronal plane correction in terms of the hip-knee-ankle angle, (as measured from full length weight bearing x-rays) |
9 months post-randomisation (6 months post-surgery) |
|
| Secondary |
Number of patients (%) achieving a pre-specified difference between planned and achieved coronal plane correction |
The number of patients who have difference between planned and achieved correction of less than 3 degrees in each treatment arm will be compared at 9 months post randomisation. |
9 months post-randomisation (6 months post-surgery) |
|
| Secondary |
Change in coronal plane location of peak loading during gait, in comparison to baseline, measured by Video Vector |
Video Vector Analysis (VVA) will be used at baseline and at 9 months post randomisation. VVA simultaneously records ground reaction force data from a force plate and video data from a video camera focussed on the lower limb of a participant. This enables the magnitude, orientation, and location of the ground reaction force to be determined relative to the limb under investigation. |
9 months post-randomisation (6 months post-surgery) |
|
| Secondary |
Operative time in minutes |
The difference in operative time (knife to skin - dressings on) and theatre time (into anaesthetic room - out of theatre) between the treatment arms will be compared. |
At procedure |
|
| Secondary |
Patient reported outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) |
KOOS is a patient reported outcome measure derived from 5 subscales; symptoms (including stiffness), pain, function (daily living), function (sports and recreation activities) and quality of life with scores ranging from 0 - 100, a higher score indicating better health. |
Baseline, 6 and 12 months post-surgery |
|
| Secondary |
Patient reported outcomes - EQ-5D-5L (EuroQol, 5 Dimension, 5 Levels) |
The EQ-5D-5L is a validated, generalised, health related quality of life questionnaire consisting of 5 domains related to daily activities with a 5-level answer possibility, which will be converted into multi-attributed utility scores using established algorithms. |
Baseline, 6 and 12 months post-surgery |
|
| Secondary |
Patient reported outcomes - Visual analogue scale (VAS) pain score |
VAS will be used to measure patient reported pain. Patients will be requested to mark on a scale of 0 (no pain) to 10 (worst possible pain) the number that represents their knee pain. A second VAS score will measure soft tissue irritation. Patients will be requested to mark on a scale of 0 (no irritation) to 10 (worst possible irritation) the number that represents their amount of irritation they feel from the plate in their knee. |
Baseline, 6 and 12 months post-surgery |
|
| Secondary |
Patient reported outcomes - University of Carolina, Los Angeles Activity Score (UCLA Activity Score) |
The UCLA Activity Score is a scale ranging from 1 to 10. The patient indicates their most appropriate activity level, with 1 defined as "wholly inactive, dependent on others, and cannot leave residence" and 10 defined as "regularly participates in impact sports". |
Baseline, 6 and 12 months post-surgery |
|
| Secondary |
Patient reported outcomes - Satisfaction and transition |
Participants will be asked how satisfied they are with their knee, how the problems related to their knee compare to before their operation and how willing they would be to have the operation again. General health will also be collected, and the participants will be asked to compare their general health now, to one year ago. |
6 and 12 months post-surgery |
|
| Secondary |
Patient reported outcomes - Health resource use (visits to primary care and hospital care services) |
This study will collect information on participants' health resource use, including time in operating theatre, visits to primary care, and hospital care services, during the follow-up. Summaries will be presented by trial arm and mean differences with 95% confidence intervals. |
6 and 12 months post-surgery |
|
| Secondary |
Knee range of motion (ROM) |
ROM flexion and extension will be measured (in degrees) at baseline and nine months post randomisation. |
9 months post-randomisation (6 months post-surgery) |
|
| Secondary |
Safety - rates of AEs / ADEs |
Safety data will be collected throughout the duration of the trial, to determine the rates of Adverse Events and Adverse Device Effects. |
Up to one year post-surgery |
|
| Secondary |
Examine relationship between correction, change in loading and clinical outcomes (Calculated change in knee loading resulting from osteotomy correction from computer models of each patient). |
Computer models based upon the CT geometry and informed by the achieved correction and video vector analysis will be used to calculate the change in knee loading due to the HTO surgery for each patient. This will enable the relationship between amount of correction, change in loading and outcome to be examined with the aim of optimising HTO surgery. |
9 months post-randomisation (6 months post-surgery) |
|
