Evaluation of the Clinical Outcomes of the Total Knee Prosthesis With Posterior Stabilization Implanted With the Use of Inertial Sensors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Knee injury and Osteoarthritis Outcome Score
研究概览
简要总结
evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 50 years of age or older and less than 85 years of age (>50 and <85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
- •to. Primary or secondary osteoarthritis
- •b. Collagen disorders and/or avascular necrosis of femoral condyle
- •c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture <10°) -
- •Patients consent and able to complete scheduled study procedures and follow-up assessments.
- •Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
排除标准
- •Simultaneous participation in other studies
- •Patients not capable of understanding and wanting and therefore unable to sign the informed consent
- •Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
研究组 & 干预措施
Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device
干预措施: Knee arthroplasty (Device)
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score
时间窗: 24 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee Society Score
时间窗: 24 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Forgotten joint score
时间窗: 24 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Western Ontario and McMaster Universities Arthritis Index
时间窗: 24 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
36-Item Short Form Health Survey
时间窗: 24 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Knee Society Score
时间窗: at baseline (day 0)
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee Society Score
时间窗: 6 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee Society Score
时间窗: 12 months
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Western Ontario and McMaster Universities Arthritis Index
时间窗: at baseline (day 0)
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Western Ontario and McMaster Universities Arthritis Index
时间窗: 6 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Western Ontario and McMaster Universities Arthritis Index
时间窗: 12 months
The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Knee injury and Osteoarthritis Outcome Score
时间窗: at baseline (day 0)
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score
时间窗: 6 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score
时间窗: 12 months
The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
36-Item Short Form Health Survey
时间窗: at baseline (day 0)
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
36-Item Short Form Health Survey
时间窗: 6 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
36-Item Short Form Health Survey
时间窗: 12 months
is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.
Forgotten joint score
时间窗: at baseline (day 0)
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Forgotten joint score
时间窗: 6 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Forgotten joint score
时间窗: 12 months
a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
次要结局
- Radiographic evaluation of prosthetic femoral component positioning(5 days after index surgery)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli