NCT05719935招募中不适用
The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Range of Motion (as assessed by physician)
研究概览
简要总结
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study.
The main questions it aims to answer are:
- What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery?
Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:
- •osteoarthritis or post-traumatic arthritis
- •scapholunate advanced collapse (SLAC/SNAC wrist),
- •inflammatory arthritis (rheumatoid, psoriatic, other),
- •crystalline advanced collapse (SCAC),
- •STT advanced collapse (STTAC),
- •ulnar translocation,
- •Kienbӧck disease,
- •radial malunion
排除标准
- •<18 years of age
- •>85 years of age
- •Prisoners
- •Pregnant women
- •Contraindications to receiving the KinematX:
- •Local, distant or systematic acute or chronic soft tissue or bony infection
- •Physiologically or psychologically compromised patient
- •Active wrist synovitis or severe carpal bone erosion
- •Suspected or documented metal allergy or intolerance
- •Insufficient extensor tendons
- •Inadequate skin, bone, neural or vascular status
- •Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology
- •Osteomyelitis
- •Uncontrolled/untreated osteoporosis or metabolic bone disease
- •Metabolic or endocrinologic bone disorders
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
结局指标
主要结局
Range of Motion (as assessed by physician)
时间窗: Up to 10 years
Flexion, Extension, Ulnar, Radial
次要结局
- PROMIS Upper Extremity Physical Function 7a(3 months, 6 months, yearly up to 10 years post-surgery)
- PROMIS Pain Interference 8a(3 months, 6 months, yearly up to 10 years post-surgery)
- PROMIS Global 10(3 months, 6 months, yearly up to 10 years post-surgery)
- Grip and pinch strength (as assessed by physician)(3months, 6 months, yearly up to 10 years post-surgery)
- Patient-Rated Wrist Evaluation Score (PRWE)(3 months, 6 months, yearly up to 10 years post-surgery)
- Percentage of patients requiring revision surgery for their implant (with or without implant replacement)(3 months, 6 months, yearly up to 10 years post-surgery)
- Hospital for Special Surgery Wrist Surgery Expectations Survey(Pre-operative and yearly up to 10 years post-surgery)
- Percentage of patients experiencing post-operative complications(3 months, 6 months, yearly up to 10 years post-surgery)
研究者
研究点 (4)
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