Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Harris Hip Score (HHS)
研究概览
简要总结
This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary osteoarthritis of the hip necessitating primary hip replacement,
- •Suitability for straight cementless stem,
- •Adult male and female under 75 years old,
- •Ability to give informed consent ,
- •Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
排除标准
- •Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component
- •Post-traumatic deformity in the affected hip,
- •Patient suffering from Inflammatory arthritis including rheumatoid arthritis,
- •Patient suffering by congenital or developmental deformity,
- •Severe osteoporosis,
- •History of surgery in the affected hip,
- •Perioperative fracture,
- •Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
- •Patients with a history of active infection
- •Pregnant women or those seeking to become pregnant
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Veterans Rand 12 (VR-12)
时间窗: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in your health using the Veterans Rand 12
Hip Disability and Osteoarthritis Outcome Score (HOOS)
时间窗: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score
Oxford Hip Score (OHS)
时间窗: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score
EuroQol 5 dimension (EQ-5D)
时间窗: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in quality of life and joint movement using the EQ-5D
次要结局
- Radiographic analysis(pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.)