Pre-Op Total Hip Arthroplasty Modelling: Individualized Care, Improved Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Muscle area
研究概览
简要总结
Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of the hip requiring primary THA
- •40 years of age or older
- •BMI <40 kg/m2
- •able to provide informed consent, able and willing to do study assessments and follow instructions
排除标准
- •prior surgery on the indicated hip with insertion of hardware
- •prior surgery on the lower spine with insertion of hardware
- •hip and/or spinal fixed deformities or inflammatory/ossification processes of the spine (e.g. DISH, ankylosing spondylolisthesis)
- •limitations to range of motion of the contralateral hip
结局指标
主要结局
Muscle area
时间窗: 6 months post-op
CT examination measuring muscle cross-sectional area (in mm2).
Quantification of fluid.
时间窗: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
Soft tissue impingement
时间窗: 6 months post-op
MRI examination. Measuring acetabular angle of anteversion.
Acetabular cup position
时间窗: 6 months post-op
CT examination. Measuring acetabular cup inclination and anteversion in degrees.
Degree of heterotopic ossification
时间窗: 6 months post-op
CT examination. Classification of heterotopic ossification based on Brooker Classification.
Muscle density
时间窗: 6 months post-op
CT examination measuring radiological density (in HU).
Integrity of the periarticular muscles.
时间窗: 6 months post-op
MRI examination. Grading based on the Goutallier classification.
Protrusion length
时间窗: 6 months post-op
CT examination. Length of protrusion in the sagittal and axial view.
Acetabular cup loosening
时间窗: 6 months post-op
CT examination. Presence od acetabular cup loosening, indicated by periprosthetic radiolucency \> 2 mm in width.
Joint effusion.
时间窗: 6 months post-op
MRI examination. Grading according to Mitchel et al. 1986
Capsular scarring
时间窗: 6 months post-op
MRI examination. Measuring the joint capsule in its thickest part.
Heterotopic ossification in periarticular soft tissues.
时间窗: 6 months post-op
MRI examination. Classification of heterotopic ossification based on Brooker Classification.
次要结局
- VR-12(3- and 6-months post-op)
- Oxford Hip Score(3- and 6-months post-op)
- WOMAC questionnaire(3- and 6-months post-op)
- UCLA Activity Score(3- and 6-months post-op)
- Novel questionnaire(3- and 6-months post-op)
- Harris Hip Score(3- and 6-months post-op)
研究者
Brent Lanting
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's