NCT06173713招募中不适用
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions
Canadian Radiostereometric Analysis Network2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Migration - Shell
研究概览
简要总结
This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized.
The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation. Additionally, the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ_2018_02.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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 who 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 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 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 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/m2.
结局指标
主要结局
Migration - Shell
时间窗: 2 Years
The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA.
Migration - Stem
时间窗: 2 Years
The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA.
次要结局
- Subsidence - Emphasys Stem(6 months, 1 Year)
- Other RSA measurements - Emphasys Shell(6 Weeks, 6 months, 1 year and 2 years)
- Other RSA measurements - Emphasys Stem(6 Weeks, 6 months, 1 year and 2 years)
- Head Penetration (in mm)(1 year and 2 years)
- Harris Hip Score(Pre-op, 6 weeks, 6 months, 1 year and 2 years)
- Subsidence - Emphasys Shell(6 months, 1 Year)
- HOOS Jr.(Pre-op, 6 weeks, 6 months, 1 year and 2 years)
- Forgotten Joint Score (FJS-12)(Pre-op, 6 weeks, 6 months, 1 year and 2 years)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Registry Study in MSI/dMMR Solid TumorsDMMR CancerMSI-HSolid TumorNCT06004713Peking University Cancer Hospital & Institute190
已完成
不适用
HAART Model 300 Annuloplasty RingAortic RegurgitationNCT01400841Biostable Science & Engineering18
已完成
不适用
A Prospective, Multi-Center, Non-Randomized Study of the BD Bard COVERA™ PLUS Vascular Covered Stent in the Treatment of Iliac Artery DiseaseTreatment of stenoses and occlusions in common/external iliac arteriesI73.9Peripheral vascular disease, unspecifiedDRKS00017906BD, Angiomed GmbH & Co. Medizintechnik KG101
终止
不适用
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)Stress Urinary IncontinenceNCT01029106Sunnybrook Health Sciences Centre125
已完成
4 期
R3 Acetabular Hip system in patients with degenerative joint disease.Degenerative joint disease.Musculoskeletal - Other muscular and skeletal disordersACTRN12608000234314Smith & Nephew70