Multi-Center, Non-controlled, Prospective Radiostereometric Analysis of the Pinnacle Acetabular Shell
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
研究概览
简要总结
The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.
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
- 否
入选标准
- •Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck
- •Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes
- •Individuals who are willing and able to return for follow-up as specified by the study protocol
- •Individuals who are a minimum age of 21 years at the time of consent
- •Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol
排除标准
- •Individuals have active local or systemic infection
- •Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery
- •Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft 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 that 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 following 6 months at the time of consent into this study
- •Individuals that have amputations in either leg that would impact rehabilitation following surgery
- •Individuals who are bedridden.
- •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 psychological disorders 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 severe 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/m2.
结局指标
主要结局
Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years
时间窗: At 6 week and 2 years
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined
Patient Reported Outcome Measures (PROMs)- HOOS Jr.
时间窗: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome).
Patient Reported Outcome Measures (PROMs)- FJS-12
时间窗: At 6 weeks, 3 months, 6 months, 1 year and 2 years
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness.
次要结局
- Other RSA Measurements (X-Translations)(At 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Other RSA Measurements (Z-Translations)(At 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Other RSA Measurements (Rotations)(At 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Linear Head Penetration(At 1 year and 2 years)
- Patient Reported Outcome Measures (PROMs)- Harris Hip Score(Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years)
- RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year(At 3 months, 6 months and 1 year)