Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Stem Survival Rate
研究概览
简要总结
The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions.
The results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.
详细描述
Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions [2,3]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Subject agrees to comply with the required postoperative management and follow-up evaluations
- •Undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment
- •Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
- •Patient signed Informed Consent.
排除标准
- •Body Mass Index (BMI) > 40 kg/m2
- •Poor general state of health
- •Acute and chronic infections, local and systemic
- •Pharmaceutical or other drug abuse, alcoholism
- •Allergies to implant materials
- •Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
- •Insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis
- •Severe osteoporosis
- •Foreseeable overload/ overstressing of the joint prosthesis
- •Acetabular defects
- •Female patient who is pregnant or plans to became pregnant during the course of the study
- •Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
- •Patient who has not signed the Informed Consent
结局指标
主要结局
Stem Survival Rate
时间窗: Up to 5 years
The survival of the stem
次要结局
- Complication Rate(Up to 5 years)
- Reoperation Rate(Up to 5 years)
- Harris Hip Score (HHS)(Up to 5 years)
- Oxford Hip Score (OHS)(Up to 5 years)
- Forgotten Joint Score (FJS)(Up to 2 years)
- Mid Thigh Pain(Up to 5 years)