Continuation of Patient Follow-up to 2 Years for the Pinnacle RSA and Pinnacle DM RSA Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
研究概览
简要总结
The proposed study is a continuation of two prospective, multi-centre, non-controlled studies of the Pinnacle and Pinnacle Dual Mobility total hip arthroplasty systems, originally initiated by DePuy Synthes (DSJ_2018_02 and DJS_2019_02, respectively).
详细描述
The primary study objective is to establish the mean superior migration of the Pinnacle Gription Sector acetabular cup, irrespective of standard or dual mobility articulation, using model-based radiostereometric analysis. As both prior studies utilize the same acetabular component, a combined analysis will be performed with an additional sub-analysis on those with a Pinnacle Dual Mobility system. Additional objectives include comparison of acetabular cup migration between surgical approach groups (posterolateral, direct lateral, direct anterior) at all time points, linear head penetration at 1 and 2 years, as well as functional and health status outcomes. Patients will be followed to the original end point of 2 years post-surgery using the same radiographic and patient-reported outcome measures at the primary studies; Harris Hip Score, Hip Evaluation, HOOS Jr., and Forgotten Joint Score. Results of this study will be published in orthopaedic journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who were enrolled on the DSJ_2018_02 and DSJ_2019_02.
排除标准
- •Individuals have active local or systemic infection.
- •Individuals who have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of bone fracture and/or the lack of adequate bone to support the implant(s).
- •Individuals with Charcot's or Paget's disease.
- •Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
- •Women who are pregnant or lactating.
- •Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the 6 months following the time of consent into this study. Individuals that have amputations in either leg that would impact rehabilitation following surgery.
- •Individuals who are bedridden per the Investigators determination.
- •Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- •Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- •Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- •Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia.
- •Subject has a medical condition with less than 2 years life expectancy.
- •Individual has a BMI >45 kg/m
- •DSJ-2019-02 only: Individuals who require revision arthroplasty and have a well-fixed non-DePuy Synthes femoral stem or a well-fixed DePuy Synthes femoral stem that does not have a polished neck
结局指标
主要结局
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
时间窗: Post-op: 6-weeks, 3-months, 6-months, 1-year, 2-year
Stability over a period of two year measured by migration (mm) with Röntgen Stereometric Analysis
次要结局
- Complications(Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively)
- Subsidence profiles(6-months, 1-year, 2-year)
- Pain and Function(Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively)
- Change of functional outcome over 2 year follow-up period (Harris Hip Score)(Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively)
- Forgotten Joint Score (FJS)(Preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively)