A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With CL TRAUMA Cemented Femoral Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The primary endpoint is based upon Harris Hip score evaluation.
研究概览
简要总结
Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female;
- •Age > 18 years old;
- •All patients must give written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC);
- •Adult patients in whom a decision has already been made to perform a partial or total hip arthroplasty with CL TRAUMA femoral stem as per indication for use. The decision to implant CL TRAUMA must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accordance with routine clinical practice at the study site concerned;
- •Patients suffering from: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; or suffering from rheumatoid arthritis; or patients requiring treatment of femoral head and neck fractures;
- •Patients able to comply with the protocol.
排除标准
- •Adult patients with any CL TRAUMA femoral stem contraindication for use as reported in the current local Instruction for use;
- •Patients with active or any suspected infection (on the affected hip or systemic);
- •Patients suffering from acute or chronic osteomyelitis;
- •Patients with confirmed nerve or muscle lesion compromising hip joint function;
- •Patients with vascular or nerve diseases affecting the concerned limb;
- •Patients with poor bone stock (such as osteoporosis or extended previous revision surgery) compromising the stability of the implant;
- •Patients with metabolic disorders which may impair fixation and stability of the implant;
- •Any concomitant disease and dependence that might affect the implanted prosthesis;
- •Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials;
- •Patients currently participating in any other surgical intervention studies or pain management studies;
- •Female patients who are pregnant, nursing or planning a pregnancy.
研究组 & 干预措施
CL TRAUMA implanted patients
Patients who underwent hip arthroplasty with CL TRAUMA cemented femoral stem from 2017 to 2023.
干预措施: CL TRAUMA femoral stem (Device)
结局指标
主要结局
The primary endpoint is based upon Harris Hip score evaluation.
时间窗: Performed only at survival follow-up (up to 7 years).
The primary endpoint is based upon patients' clinical recovery at the Survival Follow-up visit measured as Harris Hip Score greater than 80. The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and it is intended to evaluate various hip disabilities and methods of treatment in an adult population. It is a clinical outcome measurement administered by a qualified health care professional, such as a physician or a physical therapist. There are ten items covering four domains. The domains are: pain, function, absence of deformity, and range of motion. The maximum score is 100 points. Results can be interpreted with the following: * \< 60 = failed result; * 60-69 = poor result; * 70-79 = fair; * 80-90 = good * 90-100 = excellent.
次要结局
- Radiographic implant evaluation and stability assessment at different routinely post-operative timepoints.(Performed at discharge, 1 month follow-up, 2 years follow-up and at survival follow-up (up to 7 years).)
- Survivorship of the implant (Kaplan-Meier estimate) after surgery at survival follow-up.(Performed only at survival follow-up (up to 7 years).)
- Safety assessment(From surgery to survival follow-up (up to 7 years).)