A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 303
- 主要终点
- Mean Harris Hip Score
研究概览
简要总结
This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.
详细描述
The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.
The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically
- •Primary osteoarthritis or secondary coxarthritis
- •Inflammation of the hip: rheumatoid arthritis, etc.
- •Femoral neck fracture
- •Avascular necroses of the femoral head
- •Sequelae from previous operations on the hip, osteotomies, etc.
- •Congenital hip dysplasia
- •Additional inclusion criteria include:
- •18 years of age or older
- •Subjects willing to return for follow-up evaluations
- •Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)
排除标准
- •Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem
- •Absolute contraindications include:
- •Local or systemic infections.
- •Severe muscular, neurological or vascular deficiencies of the extremity involved
- •Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
- •Concomitant disease likely to affect implant function
- •Allergy to any of the components of the implant
- •Patients weighing more than 110 kg
- •Additional exclusion criteria:
- •Subjects unable to co-operate with and complete the study
- •Dementia and/or inability to understand and follow instructions
- •Neurological conditions affecting movement
- •Patient over 18 under law supervision
研究组 & 干预措施
GTS cementless stem
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
干预措施: GTS cementless stem (Device)
结局指标
主要结局
Mean Harris Hip Score
时间窗: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
次要结局
- Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling(10 years post-surgery.)
- Patient Satisfaction(Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery)
- Adverse Events/Complications(From surgery through the 10-year post-operative follow-up period.)
- Revision-Free Survivorship Through 10 Years(From implantation through 10 years post-operatively)