Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 412
- 试验地点
- 8
- 主要终点
- Hip Dislocation
研究概览
简要总结
The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
详细描述
This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (>10 drinks per week), acute displaced femoral neck fracture, age > 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation > 115 degrees).
排除标准
- •Less than 18 years of age
- •Revision THA
- •spinopelvic fusion that is more recent than 6 months prior to THA
- •isolated cervical or thoracic fusion
- •intent to undergo a revision spinopelvic fusion within one year of their index THA
- •a history of prior infection in the affected hip
- •a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
- •or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
结局指标
主要结局
Hip Dislocation
时间窗: 10 years following their index surgical procedure.
The rate of prosthetic dislocation between the two cohorts
次要结局
- Radiographic signs of loosening and proper component placement.(10 years following their index surgical procedure.)
- Complications(Complications will be assess up to 10 years following their index surgical procedure)