A Prospective, Non-randomized, Consecutive Series, Multicentre, Observational Study to Evaluate the Clinical Outcome of ceramic-on- Ceramic Hip Resurfacing Arthroplasty Using the Ceramic, Non-porous, Non-cemented H1 Hip Resurfacing Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- EQ-5D Health-Related Quality of Life Questionnaire
研究概览
简要总结
This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively.
The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship.
The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.
详细描述
Investigation type: Premarket study to receive a CE marking, followed by post-marketing surveillance follow-up.
Investigation design: Multi-centre, prospective, non-randomized, observational study
Investigation objectives:
The primary objective is to confirm the safety and efficacy of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the H1 hip resurfacing compared to a literature reference rate of the Birmingham hip resurfacing (BHR).
The secondary objective is to demonstrate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis with its metal-free articulation compared to MoM hip resurfacing in the absence of metal ion release. Additional goals are to demonstrate non-inferiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to hip resurfacing with regard to patient reported outcome measures, objective clinical and functional outcomes, and radiological assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia)
- •Patient is eligible for hip resurfacing arthroplasty: i.e. has sufficient bone stock at the level of the femoral head (<1/3 necrosis of the head) and neck (not osteopenic/porotic, see
排除标准
- •Patient is between 18 and 70 years old
- •Patient willing to comply with study requirements
- •Patient is legally entitled and able to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the informed consent form approved by the Ethics Committee.
- •Patient plans to be available through ten (10) years postoperative follow-up
- •Patient is able to understand the native language of the country of the trial centre
- •Exclusion Criteria:
- •Patient has a BMI greater than 40
- •Patient suffers from an active inflammatory joint disorder
- •Patient has an active infection or sepsis (treated or untreated)
- •Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head) or in general as in severe osteopenia or osteoporosis (Tscore < -2.5 as measured with BMD)
- •At the time of enrolment, patient has one or more of the following arthroplasties that have been
- •Implanted less than 6 months before the current hip arthroplasty:
- •Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
- •Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty
- •Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications.
- •Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •Patient has a known alcohol or drug abuse
- •Patient has an immunosuppressive disorder
- •Patient has a malignant tumour, metastatic, or neoplastic disease
- •Patient has severe comorbidities or a limited life expectancy
- •Patient lacks capacity to consent
- •Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study
- •Patient is not willing or able to sign an informed consent form
- •Patient pregnant or breast feeding
- •Patient is not able or willing to come to follow-up visits
- •In addition, the following exclusion criteria are applied to the 20 patients (Cohort 1 and Cohort 1.1) in the safety study in whom metal ion measurements will be performed, since those conditions may be associated with elevated metal ion levels and could complicate the interpretation of the metal ion results:
- •Patients who already received another joint replacement, hip, knee, shoulder, ankle.
- •Workers in the paint, diamond, leather or other industries producing Co or Cr dust.
- •Patients taking medication, vitamins or food supplements containing Co or Cr and not able or willing to discontinue those.
研究组 & 干预措施
Cohort 1 - Safety
Cohort 1 will consist of the first 20 participants recruited into the study for H1 Hip Resurfacing Arthroplasty. These patients will receive additional CT scans preoperatively and then post-operatively at these time points: immediately postoperatively (2days), at 6 weeks, 3 months, 6 months, 1 year and 2 years. They will have metal-ion measurements for safety analysis. Blood samples will be taken preoperatively and postoperatively at 3 months, 6 months, 1 year and 2 years.
A safety analysis of Cohort 1 will be performed at the 6 week, 3 month and 6 month post-operative stage by independent assessors. Yearly clinical evaluations will be performed until 10 years, and radiographs at 3,5,10 years. If the investigation supports the safety of the implant, the study will proceed with recruitment into Cohort 2.
干预措施: H1 Hip Resurfacing Arthroplasty (Device)
Cohort 2 - Efficacy
Cohort 2 will consist of the remaining target size population of 230 patients for H1 Hip Resurfacing Arthroplasty. They will undergo the same intervention as previously described for Cohort 1, but will not undergo metal-ion testing and reduced frequency CT-scans.
干预措施: H1 Hip Resurfacing Arthroplasty (Device)
结局指标
主要结局
EQ-5D Health-Related Quality of Life Questionnaire
时间窗: 10 years
Generic Patient Reported Outcome Measure (PROM)
Oxford Hip Score
时间窗: 10 years
Hip Specific Patient Reported Outcome Measure (PROM)
次要结局
- Clinical objective outcome measures(10 years)
- Metal ion measurements(Up till 2 years)
- Complication Rate(10 years)
- Acetabular Implant orientation(10 years)
- Femoral Implant orientation(10 years)
- Low-dose CT(Up till 2 years)