Personalised Against Standard High Tibial Osteotomy, a Prospective Multi-centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- 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.
研究概览
简要总结
A study to compare the accuracy of achieving the planned correction between personalised (TOKA) high tibial osteotomy (HTO) procedure and standard generic HTO procedure.
详细描述
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 (revised to 50) 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 (revised to 50) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing High Tibial Osteotomy
- •Male or Female, aged 18 to 65 years
- •Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
- •Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement
- •Varus deformity <20 °
- •An exemption to this may be made if the participant (in the investigators opinion) is suitable for surgery.
- •Participant is willing and able to give informed consent for participation in the study.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- •Prisoners
- •Participants with a known deep tissue sensitivity to device materials
- •Participants with an active or suspected latent infection in or about the affected knee joint
- •Participants who have received any orthopaedic surgical intervention to the lower extremities (excluding investigative surgery) within the past 12 months, or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next 12 months (including intra-articular procedures).
- •Participants who require bilateral HTO with surgery planned on their second knee within 6 months of their first operation (bilateral HTO patients are otherwise included).
- •Participants who require bilateral HTO who have had a previous unsuccessful contralateral partial replacement or HTO
- •Chronic heart failure (NYHA Stage ≥ 2)
- •Neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
- •Systemic disease diagnosis (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- •Participant is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Participant is a smoker.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
研究组 & 干预措施
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).
干预措施: TOKA (Device)
Standard (Tomofix or ActivMotion)
During HTO surgery, the standard plate will be inserted below the knee.
干预措施: Tomofix or ActivMotion (Device)
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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)
次要结局
- Number of patients (%) achieving a pre-specified difference between planned and achieved coronal plane correction(9 months post-randomisation (6 months post-surgery))
- Operative time in minutes(At procedure)
- Change in coronal plane location of peak loading during gait, in comparison to baseline, measured by Video Vector(9 months post-randomisation (6 months post-surgery))
- Patient reported outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 6 and 12 months post-surgery)
- Patient reported outcomes - EQ-5D-5L (EuroQol, 5 Dimension, 5 Levels)(Baseline, 6 and 12 months post-surgery)
- Patient reported outcomes - Visual analogue scale (VAS) pain score(Baseline, 6 and 12 months post-surgery)
- Patient reported outcomes - University of Carolina, Los Angeles Activity Score (UCLA Activity Score)(Baseline, 6 and 12 months post-surgery)
- Patient reported outcomes - Satisfaction and transition(6 and 12 months post-surgery)
- Knee range of motion (ROM)(9 months post-randomisation (6 months post-surgery))
- Safety - rates of AEs / ADEs(Up to one year post-surgery)
- Patient reported outcomes - Health resource use (visits to primary care and hospital care services)(6 and 12 months post-surgery)
- 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).(9 months post-randomisation (6 months post-surgery))
研究者
Richie Gill
Professor of Healthcare Engineering
University of Bath