Personalised Against Standard High Tibial Osteotomy (PASHiOn)
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|ClinicalTrials.gov Identifier: NCT04666571|
Recruitment Status : Not yet recruiting
First Posted : December 14, 2020
Last Update Posted : May 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Medial Knee Osteoarthritis||Device: TOKA Device: Tomofix||Not Applicable|
The trial design is a multi-centre, blinded, superiority two arm, parallel group design randomised controlled trial (RCT) of personalised (TOKA) versus standard high tibial osteotomy (HTO).
The aim of the PASHiOn trial is to establish whether digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery. Embedded within the trial is a non-randomised pre-RCT technology check and safety assessment of 5 patients (Phase 1), followed by a randomised controlled trial of 88 patients (Phase 2).
During phase 1 of the clinical investigation, 5 patients fulfilling the inclusion criteria will be recruited and assessed in an identical way to the 88 patients recruited in the main trial, but without randomisation. Recruitment of the remaining patients (Phase 2) will take place after the six-week assessment on the fifth patient is complete and the oversight committee supports progression to Phase 2.
Patients will be randomised to Phase 2 in a 1:1 ratio and patients will be blinded as to which treatment arm they receive.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Personalised Against Standard High Tibial Osteotomy, a Prospective Multi-centre Randomised Controlled Trial|
|Estimated Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||September 29, 2022|
|Estimated Study Completion Date :||September 29, 2023|
Experimental: Personalised (TOKA)
During HTO surgery, the personalised plate will be inserted below the knee.
The investigational device and comparator are two types of metal plate used to fix the bone in place during a high tibial osteotomy (HTO).
The device is a digitally planned (using individual CT scan measured anatomic data) personalised opening wedge high tibial osteotomy (HTO) procedure using a custom 3D printed surgical guide and plate.
Active Comparator: Standard (Tomofix)
During HTO surgery, the standard plate will be inserted below the knee.
The Tomofix device is used in more than 80% of HTO procedures reported upon in the United Kingdom Knee Osteotomy Register Annual Report 2018. The Tomofix procedure is similar to the TOKA procedure; however, it is not patient specific and does not use custom-made plates or jigs.
- 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. [ Time Frame: 6 weeks post-surgery ]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.
- Phase 2 - To establish if digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery. [ Time Frame: 9 months post-randomisation (6 months post-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)
- Number of patients (%) achieving a pre-specified difference between planned and achieved coronal plane correction [ Time Frame: 9 months post-randomisation (6 months post-surgery) ]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.
- Change in coronal plane location of peak loading during gait, in comparison to baseline, measured by Video Vector [ Time Frame: 9 months post-randomisation (6 months post-surgery) ]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.
- Operative time in minutes [ Time Frame: At procedure ]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.
- Patient reported outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 6 and 12 months post-surgery ]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.
- Patient reported outcomes - EQ-5D-5L (EuroQol, 5 Dimension, 5 Levels) [ Time Frame: Baseline, 6 and 12 months post-surgery ]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.
- Patient reported outcomes - Visual analogue scale (VAS) pain score [ Time Frame: Baseline, 6 and 12 months post-surgery ]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.
- Patient reported outcomes - University of Carolina, Los Angeles Activity Score (UCLA Activity Score) [ Time Frame: Baseline, 6 and 12 months post-surgery ]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".
- Patient reported outcomes - Satisfaction and transition [ Time Frame: 6 and 12 months post-surgery ]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.
- Patient reported outcomes - Health resource use (visits to primary care and hospital care services) [ Time Frame: 6 and 12 months post-surgery ]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.
- Knee range of motion (ROM) [ Time Frame: 9 months post-randomisation (6 months post-surgery) ]ROM flexion and extension will be measured (in degrees) at baseline and nine months post randomisation.
- Safety - rates of AEs / ADEs [ Time Frame: Up to one year post-surgery ]Safety data will be collected throughout the duration of the trial, to determine the rates of Adverse Events and Adverse Device Effects.
- 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). [ Time Frame: 9 months post-randomisation (6 months post-surgery) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666571
|Contact: Lisa Poultonfirstname.lastname@example.org|
|Principal Investigator:||Richie Gill, Prof||University of Bath|