A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
研究概览
简要总结
This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years post-surgery.
详细描述
This is a single arm, consecutive series study to collect relevant clinical, laboratory and radiological data in up to 26 subjects, who have been implanted with the SMF Short Modular Femoral Stem THA system at 1 site in Australia.
The Baseline visit will be determined as the first visit to site after Ethics approval. This will be approximately 8-9 years post implant. Enrolled subjects will be followed up to 20 years post SMF implant.
Eligible patients will be contacted and patient status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 12 year on-site follow-up visits for which they will provide written informed consent. Subjects who are lost to follow-up, deceased or are unwilling/unable to participate in the prospective study will be noted in the subject files and this data will be captured for analysis of study results. Data will be collected on the operative date, and implant status.
Post Baseline, the study will allow for metal ion assessments every 3 years for asymptomatic subjects and annual assessments for subjects with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the SMF implant, having ruled out all other probable causes for the subject. If the subject has elevated whole blood cobalt or chromium (defined as >7ppb) a MARS MRI or CT will be obtained. These types of imaging techniques are aimed at detecting inflammatory degenerative evolution of peri articular soft tissues including pseudo-tumours. A functional Questionnaire, HOOS JR Questionnaire will be completed at all patient site visits.
Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has undergone primary total hip arthroplasty with the SMF short modular femoral stem at the study site and still has the original implant at the time of Ethics Committee approval of the study.
- •The participant is willing and able to participate in follow-up visits at the study site.
排除标准
- •The Subject, in the opinion of the PI, has an emotional or neurological condition that would affect their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- •Subject is known to be at risk for lost to follow-up or failure to return for scheduled visits.
结局指标
主要结局
Number of Participants With Cobalt (Co) and Chromium (Cr) Metal Ions > 7 Parts-Per-Billion (Ppb)
时间窗: Baseline to study completion, up to 20 years
Number of participants with whole blood cobalt (Co) and/or chromium (Cr) \> 7 ppb (Yes/No). Participants as 'Yes' to Co and/or Cr will have Metal Artifact Reduction Sequence (MARS) Magnetic Resonance Imaging (MRI) performed (or Computerized tomography (CT) if MRI is contraindicated). This is used to detect pseudotumors, abductor muscle atrophy, and tendinous pathology in patients with painful metal-on-metal (MOM) hip arthroplasty.
Metal Ion Level
时间窗: Baseline to Study Completion, up to 20 years
All participants at Baseline and every three years afterwards up to 20 years will have whole blood collected for metal ion testing of whole blood cobalt (Co) and chromium (Cr). Symptomatic participants with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the implant will have whole blood collected for metal ion testing of cobalt and chromium annually.
次要结局
- Number of Participants With Short Modular Femoral (SMF) Stem Revision(Study Completion, up to 20 years)
- The Hip Osteoarthritis Outcomes Score Junior (HOOS JR) Questionnaire(Baseline to study completion, up to 20 years)
- Radiographic Assessment: Loosening(Baseline to study completion, up to 20 years)
- Radiographic Assessments: Surface Wear(Baseline to study completion, up to 20 years)