Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis (The MARVEL Project): A Pragmatic, Multicentre, Blinded Randomised Controlled Trial With Multi-domain Investigations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 2
- 主要终点
- Change in Forgotten Joint Score
研究概览
简要总结
The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis. It will also aim to review the longer-term safety and efficiency effects of using this device.
The main questions it aims to answer are:
- Does VRAS device-assisted total knee replacement improve patient outcomes (such as their function, satisfaction, and pain) when compared to non-robotic-assisted total knee replacement?
- Does VRAS device-assisted total knee replacement improve clinical outcomes (such as revision risk, complications, and hospital length of stay) when compared to non-robotic-assisted total knee replacement?
- Does VRAS device-assisted total knee replacement improve functional outcomes (including biomechanical motion analysis) when compared to non-robotic-assisted total knee replacement?
- What are the economic and efficiency effects of VRAS device-assisted total knee replacement compared to non-robotic-assisted total knee replacement?
- What are the human factor and learning curve effects of introducing VRAS device-assisted total knee replacement into healthcare teams?
- Are there any differences in safety and adverse event incidence between VRAS device-assisted total knee replacement and non-robotic-assisted total knee replacement?
Participants will:
- Be randomised to receive a total knee replacement using either regular non-robotic-assisted methods, or with the use of the VRAS device.
- Be assessed pre-operatively at the clinic, and then at 6 weeks, 6 months, and 12 months following date of operation. At these appointments patients will answer questionnaires, receive an x-ray (pre-operatively, and at 6 months post-operatively), and a subgroup will be reviewed in the motion analysis laboratory (pre-operatively, and at 6 months post-operatively).
- Have their longer-term outcomes including any revision operations monitored out to 10 years through national registry data linkage (no actual follow-up for patients after 12 months).
详细描述
This multicentre, pragmatic, parallel-group, blinded RCT will compare VELYS robot-assisted functional alignment with conventional total knee arthroplasty. The trial will employ a clearly defined, reproducible surgical protocol that will incorporate evaluation of the study cohort using: established clinical and patient-reported outcome measures (PROMs); gold-standard three-dimensional (3D) motion analysis to objectively evaluate functional outcomes; detailed examination of intraoperative knee kinematics, pre-/post-operative hip-knee-ankle radiographic data, and healthcare system effects including economic, efficiency, and human factor measures.
Objectives
The primary objective is to compare knee-specific health outcomes in patients undergoing TKA performed with VELYS robot-assisted (raTKA) using functional alignment versus TKA performed manually (mTKA) using conventional instrumentation. The primary outcome measure will be differences between the two intervention groups (using an intention-to-treat approach) with regard to change in Forgotten Joint Score (FJS) preoperatively versus 6 months post-surgery. The secondary objectives are to:
- Compare PROMs (FJS, EQ-5D-5L, Oxford Knee Score [OKS], satisfaction [numeric rating scale; NRS], 4-part Likert scale], pain [101-point scale VAS]) at 6 weeks, 6 months, and 12 months;
- Correlate these outcomes with radiographic alignment and intra-operative data;
- Evaluate biomechanical outcomes using motion analysis laboratory assessment;
- Functional and activity-related outcomes;
- Evaluate the economic and efficiency effects of imageless raTKA relative to mTKA;
- Evaluate the human factor effects of introducing a new RAS into healthcare teams;
- Assess surgical safety and the incidence of adverse events in both groups.
Null hypothesis The null hypothesis is that functionally aligned raTKA using the VELYS imageless system does not result in a greater early improvement in knee-specific outcomes, as measured by change in Forgotten Joint Score at 6 months, compared with conventional mTKA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study is a randomised controlled trial with patient and outcome assessor blinding. It is not possible to blind surgeons given the nature of the interventions. Non-surgical clinical staff (e.g. ward nurses and allied health professionals) will be blinded. Femoral and tibial tracker pins will be placed within the surgical incision, avoiding the need for accessory incisions in raTKA cases or sham incisions to aid blinding in mTKA cases. Documentation will be redacted appropriately to prevent inadvertent unblinding of clinicians. PROMs will be completed independently by participants. Radiographic assessments and biomechanical analyses will be performed by assessors who are blinded to treatment allocation. All study data will be anonymised and the study arm concealed before the conduct of data analysis. No unblinding procedures are planned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years
- •Primary knee OA
- •Requiring TKA
- •Suitable for either raTKA or mTKA
- •Capable to provide written informed consent
- •Capable and willing to complete outcome measures throughout study period
排除标准
- •Inflammatory arthritis
- •Significant symptomatic hip, ankle, or contralateral knee OA
- •Prior TKA or major injury or major surgery on the index knee
- •Neuromuscular gait disorders
- •BMI >45 kg/m2
- •Coronal plane deformity >15° varus/valgus on pre-op HKA radiograph
- •Fixed flexion deformity greater than 15°
- •Bone loss likely to require non-standard implants (e.g. stems, augments)
- •Severe deformity or ligament insufficiency likely to require constraint
- •Inability to comply with the required follow-up assessments or complete PROMs
- •Contraindications to any aspect of the surgical technique
研究组 & 干预措施
VELYS Robotic-Assisted Total Knee Replacement
Trial treatment, with an ATTUNE total knee replacement put in by a surgeon using robot-assistance for the bone cuts from the VELYS robot, allowing for functional alignment to be used.
干预措施: Robot-Assisted Functionally Aligned Total Knee Replacement (Device)
Manual Non-Robotic Total Knee Replacement
Current standard treatment, with an ATTUNE total knee replacement put in by a surgeon with no robot assistance, using manually-achievable alignment strategies.
干预措施: Manual Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Change in Forgotten Joint Score
时间窗: Pre-surgery to be compared with 6 months post-surgery.
Using validated Forgotten Joint Score questionnaire. Maximum score 100, minimum 0. Higher score equates to better outcome.
次要结局
- Change in Forgotten Joint Score(Measured pre-operatively, and at 6 weeks, and 12 months.)
- Absolute Forgotten Joint Score(Measured at 6 weeks, 6 months, and 12 months.)
- Oxford Knee Score(Measured pre-operatively, at 6 weeks, 6 months, and 12 months.)
- EQ-5D-5L(Measured pre-operatively, at 6 weeks, 6 months, and 12 months.)
- Satisfaction Score (Likert)(Measured at 6 weeks, 6 months, and 12 months.)
- Satisfaction (VAS)(Measured at 6 weeks, 6 months, and 12 months.)
- Pain Score(Measured at 6 weeks, 6 months, and 12 months.)
- Patient Reported Outcome Measure anchor questions (FJS)(6 months.)
- Patient Reported Outcome Measure anchor questions (OKS)(6 months)
- Radiographic Parameters (HKA)(Measured pre-operatively and at 6 months.)
- Radiographic Parameters (Component Assessment)(Measured pre-operatively and at 6 months.)
- Motion Analysis Study (KAM)(Motion analysis will take place pre-operatively and at 6 months.)
- Motion Analysis Study (Spatiotemporal gait parameters)(Motion analysis will take place pre-operatively and at 6 months.)
- Motion Analysis Study (Kinematic Parameters)(Motion analysis will take place pre-operatively and at 6 months.)
- Motion Analysis Study (Kinetic Parameters)(Motion analysis will take place pre-operatively and at 6 months.)
- Motion Analysis Study (Joint Power Parameters)(Motion analysis will take place pre-operatively and at 6 months.)
- Surgical Study (Surgical Time)(Measured peri-operatively.)
- Surgical Study (NASA Task Load Index)(Perioperative, after every surgeon's first case and every fifth case thereafter, through study completion (up to 36 months).)
- Surgical Study (Clinician Experience)(Perioperative, after every surgeon's first case and every fifth case thereafter, through study completion (up to 36 months).)
- Health Service Resource Utilisation (Clinical Contacts)(Reviewed at 6 weeks, 6 months, and 12 months.)
- Health Service Resource Utilisation (Analgesic Use)(Reviewed at 6 weeks, 6 months, and 12 months.)
- Clinical Outcomes (Re-Operation)(Continuously out to 12 months)
- Clinical Outcomes (Infection)(Continuously out to 12 months)
- Clinical Outcomes (Complications)(Continuously out to 12 months)
- Employment Outcome(Reviewed at 6 weeks, 6 months, and 12 months.)