Adequately Diagnosing Total Knee Arthroplasty Loosening: a Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 7
- 主要终点
- Failed Outcome
研究概览
简要总结
The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is:
Does the use of the AtMoves Knee System reduce the percentage of failed outcomes? A "failed outcome" is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months.
Researchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of "failed outcomes" between these groups.
During the one-year follow-up, participants in both groups will be asked to fill out questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 years or older.
- •Subjects must have underwent either unilateral or bilateral TKA surgery.
- •Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon
- •The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.
- •The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.
- •Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.
排除标准
- •A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)
- •Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.
- •Posttraumatic or congenital deformation of the leg for which the loading device does not fit.
- •Pregnancy or suspected pregnancy.
- •Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.
研究组 & 干预措施
Intervention: AtMoves Knee System group
The intervention group will undergo a CT-scan using the AtMoves Knee System. They are allowed to undergo the diagnostic pathway determined by their treating orthopedic surgeon.
干预措施: AtMoves Knee System (Device)
Control: usual care/diagnostics
The control group is not allowed to undergo a CT-scan using the AtMoves Knee System. They will undergo the diagnostic pathway determined by their treating orthopedic surgeon.
结局指标
主要结局
Failed Outcome
时间窗: 12 months
The primary outcome measure is the status of the outcome of the treatment as "failed outcome" at 12 months as determined by a change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-Physical function Short form) that is less than the minimal clinically important difference (MCID) compared to baseline KOOS-PS (MCID is set to 15). The KOOS-PS gives a score from 0-100 with higher scores reflecting better physical function.
次要结局
- Revision surgery(12 months)
- Number of Diagnostic activities(until the final diagnostic decision (up to six months))
- Cost of diagnostic activities(Upon the final diagnostic decision (up to six months).)
- Medical consumption after diagnosis(1 Year)
- Societal productivity loss after diagnosis(1 Year)
- Subject satisfaction intervention group(Day of CT-scan using the AtMoves Knee system (day 0))
研究者
Leendert Blankevoort
Associate professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)