NCT05461638撤回不适用
A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty
Medacta USA0 个研究点开始时间: 2020年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline in Forgotten Joint Score
研究概览
简要总结
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.
详细描述
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients with Medacta GMK Sphere knee system using patient specific instrumentation Medacta MyKnee. Patients will be assessed a pre-operative, operative and interim post-operative visits, week 6, month 6 and 1,2,5 & 10 years. There will be a phone survey follow up at year 3,4,6,7,8,& 9.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Ability to understand and provide written authorization for use and disclosure of personal health information.
- •Subject who are able and willing to comply with the study protocol and follow-up visits.
- •Must be 21 years or older to participate, and less than 80 years old.
- •Subjects must have osteoarthritis knee disease in the affected knee compliant with the FDA-approved indications for use of GMK Sphere knee system and MyKnee cutting blocks.
- •Patients who are candidates for Total Knee Arthroplasty and are determined to undergo a TKA using the Medacta GMK Sphere implant and MyKnee cutting blocks will be offered enrollment.
- •Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete PRO questionnaires, physical exam and radiographs.
排除标准
- •• Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant
- •The patient has a fixed flexion deformity of ≥15°
- •The patient has less than 90° of flexion
- •Patient is morbidly obese (BMI ≥40)
- •Patient with inflammatory arthritis
- •History of prior deep knee infection
- •History of alcoholism or drug abuse
- •Currently on chemotherapy or radiation therapy for neoplastic disease
- •Patient currently on immunosuppressive medications including steroids except when, (a) steroid use is less than 10mg daily, (b) other immunosuppressive medications are held for appropriate time, for example Adalimumab is held 2 weeks prior and 2 weeks after surgery
- •History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
- •Habitual use of narcotic pain medications prior to surgery (more than 2 doses daily and chronic use of a minimum 3 months)
- •History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
- •History of chronic pain issues for reasons other than knee joint pain. If the type of pain affects activities of daily living, do not enroll. If the pain is intermittent and does not affect activities of daily living, it is OK to enroll. Fibromyalgia is exclusionary.
- •Women who are pregnant
- •Patient with unstable psychiatric illness or psychosis is excluded. (Patients with stable anxiety or depression can be enrolled if PI determines that the condition does not adversely affect study outcomes & requirements)
- •Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
- •Prior surgery on the target knee other than arthroscopy and/or arthroscopically-assisted ligament reconstruction
- •Prior high tibial osteotomy (HTO) or femoral osteotomy
- •Malunion of fracture of a tibia or femur
- •Patient with a neuromuscular or neurosensory deficiency
- •Patient with history of knee fusion in the affected joint
结局指标
主要结局
Change from baseline in Forgotten Joint Score
时间窗: Post operative 4-132 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score
次要结局
- Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)(Baseline to Post operative 4-132 months)
- Change in Baseline in Knee Alignment(Baseline to Post operative 4-132 months)
- Change from baseline in PROMIS(Baseline to Post operative 4-132 months)
- Change from Baseline of Implant Position Fixation(Baseline to Post operative 4-132 months)
- Change from baseline in Knee Society Score(Baseline to Post operative 4-132 months)
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