A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adherence to Lewinnek Safe Zone
研究概览
简要总结
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
详细描述
The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.
This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
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
- 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
- 是
入选标准
- •Patients requiring primary total hip arthroplasty
- •Patients willing and able to comply with follow-up requirements
- •Patients willing to sign an Institutional Review Board approved informed consent form.
排除标准
- •Patients with Body Mass Index >45
- •Patients who are <18 years of age
- •Patients with an active infection or suspected latent infection in or about the hip joint
- •Bone stock that is inadequate for support or fixation of the prosthesis
- •Previous major hip surgery excluding hip arthroscopy
- •Total hip arthroplasty using cement fixation or resurfacing
研究组 & 干预措施
Control
Traditional THA.
Intervention
Robotic-arm assisted THA.
干预措施: Robotic-Arm Assisted THA (Procedure)
结局指标
主要结局
Adherence to Lewinnek Safe Zone
时间窗: 6 month
5-25 degrees of anteversion; 30-50 degrees of inclination.
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
时间窗: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.
时间窗: 1 Year
The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
时间窗: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.
时间窗: 1year
The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)
次要结局
未报告次要终点
研究者
Matthew Dietz, MD
Associate Professor, Chair
West Virginia University