Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Acetabular Cup Survivorship
研究概览
简要总结
The Custom Resurfacing (CR) Implants are indicated for use for the reduction or relief of pain and/or improved hip function all skeletally mature patients where a total joint replacement is indicated, and where there is no other suitable, commercially distributed device available.
The Resurfacing System is a metal-on-polyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.
The custom-Made Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component.
The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis.
This study will assess the following endpoints:
- The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up.
- Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups.
- Absence of subsequent surgical intervention at the acetabulum of there operated hip.
- Absence of serious, device-related adverse events.
- Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.
详细描述
This is a retrospective and prospective study that will include a 41patients who were implanted with the JointMedica Custom-Made Hip Resurfacing device in the UK.
Patients will be invited to consent to participate in this study, which will require their attendance of a follow-up standard of care visit to gather clinical data on the safety and performance of their index hip, undergo an x-ray imaging and complete two questionnaires to assess their functionality and outcomes.
Patient data will be entered into electronic data capture systems and x-rays will be submitted to a core imaging laboratory, MMI, for analysis to assess the state and position of their acetabular cup.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Age 21 or above at the time of the surgery.
- •Have had the JointMedica Custom-Made Hip Resurfacing device implanted between September 2020 to January 2025
- •Written informed consent given by subject
排除标准
- •There is no exclusion criteria for this study
结局指标
主要结局
Acetabular Cup Survivorship
时间窗: From the primary implantation to end through to 24 months and 27months+ post operation.
The number of acetabular cups which are functional and not requiring additional surgical intervention following the primary implantation
Radiographic Success
时间窗: Between primary implantation surgery and post-operative review at 24-months and 27+ months.
Quantitative motion assessment of the acetabular cup at implantation and follow-up visit
Serious Device-Related Adverse Events
时间窗: From primary implantation to post-operative visit at 24-months or 27+months
Occurrence and severity of adverse events including necessitation of secondary surgical intervention.
次要结局
未报告次要终点