Single-center, Randomized, Controlled, Double Blinded, 24-month Trial to Compare Robotic-assisted (MAKO) and Manual Total Knee Arthroplasty for Primary Osteoarthritis With 10 Year Follow-up for Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- Oxford Knee score OKS at 24 months
研究概览
简要总结
Background: Total knee arthroplasty is a golden standard procedure for end-stage knee osteoarthritis. However, up to 20% of the patients are not satisfied with the outcome. Recently, robotic-assisted TKAs have been developed to offer individual alignment and to achieve accuracy in positioning with more subtle soft-tissue handling, thus possibly leading into better outcome.
Hypothesis: The investigators hypnotize that, robotic-assisted TKA is superior to manual TKA for end-stage osteoarthritis in respect to functional outcome, short-term rehabilitation and cost-efficiency.
Trial desing: The investigators will conduct a single-center, randomized, controlled, double blinded superiority trial of 24-months to compare robotic-assisted and manual total knee arthroplasty in respect to functional outcome, implant positioning, short-term rehabilitation and cost-efficiency with up to 10 years follow-up for complications.
The principle outcome measure will be patient reported outcome measure (PROM) Oxford knee score (OKS) points (0-48 points) at two years after surgery. Minimal clinically important difference will be considered as 5 points. Other PROMS, patient satisfaction, short-term rehabilitation, implant positioning, knee range of motion, length of sick leave and cost efficiency will also be reported. Patients will be followed up to 10 years for complications (infection, manipulation and revisions).
This study will be conducted in Central Hospital of Satakunta (Satasairaala), Finland. The investigators will recruit 170 adult patients (aged 50-80), with end-stage (Kellgren-Lawrence grade IV) primary osteoarhritis. Patients will be randomly assingned to either robotic-assisted or manual TKA. Patients will be blinded by the intervention method used. Personnel and investigators assessing the patients and interpreting the data will also be blinded to the surgical method.
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)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 50 and below 80 years
- •End-stage Kellgren-Lawrence grade IV KOA
- •Failed conservative treatment
排除标准
- •Post-traumatic knee osteoarthritis
- •Rheumatoid arthritis
- •Previous knee infections
- •Previous knee surgery (other than diagnostic arthroscopy or meniscectomy)
- •Knee range of motion within 15 to 100 degrees
- •Mechanical axis over 15 degrees of varus or over 10 degrees of valgus
- •Body mass index over 40 kg/m2
- •Significant patellofemoral osteoarthritis (Kellgren-Lawrence grade III or IV)
- •Diabetes treated with insulin
- •Malignancy with ongoing treatment
- •Systemic glukocorticosteroid or antimetabolite medication during the last 5 years
- •Conditions that do not allow general anesthesia
- •Patients' denial for operative treatment and/or participation in the trial
研究组 & 干预措施
Robotic-assisted total knee arthroplasty
The intervention group will undergo MAKO assisted RATKA. The patients will have individualized alignment. Knee balance is achieved with bony cuts and implant positioning, to avoid soft tissue releases. A preoperative planning based on computed tomography (CT) scans is made and intraoperatively computer assisted gap balancing is performed based on the plan and patient's soft tissue envelope and native joint line. The precise pre-operative planning, balancing and alignment method has been described by Calliess T el al.
干预措施: Robotic-assisted total knee arthroplasty (Device)
Manual total knee arthroplasty
The control group will undergo manual jig-guided TKA, with bony cuts made to achieve neutral mechanical axis, and if necessary, knee balancing will be performed by soft tissue releases. Weight bearing semi-flexion radiographs and long leg radiographs are used for preoperative planning. Intramedullary guiding rod is used in femur to align the cuts in 6 to 7 degrees of valgus. Femoral component rotation is fixed to trans-epicondylar line. Tibia cuts are aligned with either intra- or extramedullary guiding rod according to the preference of the surgeon. Tibia component rotation is fixed to medial one-third of tibial tubercle. After bony cuts, knee balancing is performed with soft-tissue and ligament releases if necessary.
干预措施: Manual total knee arthroplasty (Procedure)
结局指标
主要结局
Oxford Knee score OKS at 24 months
时间窗: 24 month
Patient reported outcome measure, knee function questionnaire Oxford Knee Score (OKS) at 24 month. Scale from 0 (=worst) to 48 (=excellent) points Minimal clinically important difference considered as 5 points.
次要结局
- Oxford Knee Score at 3 and 12 months(3 and 12 months visits)
- Knee injury and Osteoarthritis Outcome Score (KOOS) at 3, 12 and 24 months(3, 12 and 24 months)
- Patient satisfaction inquiry at 3, 12 and 24 months(3, 12 and 24 months)
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 12 and 24 months.(3, 12 and 24 months)
- Working ability, part-time vs full-time(Asked at 3 month, 12 months and 24 months after the surgery)
- Life quality questionnaire 15 dimensions (15D) at 3, 12 and 24 months(3, 12 and 24 months)
- Pain at rest and during walking on visual analoque scale (VAS)(First day after the operation and at 3, 12 and 24 months)
- Opioid usage(Up to two weeks)
- Blood loss(First day after the operation)
- Working ability, lenght of the sick leave(up to 24 months)
- Working ability, physical demands of the job(Asked at 3 month, 12 months and 24 months after the surgery)
- Lenght of the hospital stay(Up to 1 week)
- Operation time(Day of the surgery)
- Post-operative CRP(First day after the operation)
- Knee swelling(First day after the operation)
- Range of knee motion (ROM)(First day after the operation and at 3, 12 and 24 months visits)
- Radiological outcome measures, alingment(Weight bearing whole leg x-rays taken 3 months post-operatively.)
- Radiological outcome measures, posterior condylar offset(post-operative knee x-rays taken within 1 week after the operation)
- Radiological outcome measures, Insall-salvati ratio(post-operative knee x-rays taken within 1 week after the operation)
- Radiological outcome measures, Overhanging(post-operative knee x-rays taken within 1 week after the operation)
- Radiological outcome measures, Notching(post-operative knee x-rays taken within 1 week after the operation)
- Complications, revisons(3, 12 and 24 months and five and ten years)
- Complications, infections(3, 12 and 24 months and five and ten years after surgery)
- Complications, knee manipulation under anestesia due stiff knee(3, 12 and 24 months and five and ten years after surgery.)
- Complications, re-admission(up to 24 months)
- Complications, unplannet emergency unit visits(up to 24 months)
- Costs(up to 24 months)
研究者
Juha Kukkonen
Docent, MD
Satakunta Central Hospital