A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Harris Hip Score (HHS)
研究概览
简要总结
This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
详细描述
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Both genders
- •A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
- •patien willingness to partecipate and signature of informed consent form
排除标准
- •local or systemic infection
- •septicaemia
- •persistent acute or chronic osteomyelitis
- •confirmed nerve or muscle lesion compromising hip joint function
- •vascular or nerve disease affecting the concerned limb
- •poor bone stock (for example due to osteoporosis) compromising the stability of the implant
- •metabolic disorders which may impair fixation and stability of the implant
- •any concomitant disease and dependence that might affect the implanted prosthsis
- •metal hypersensitivity to implant materials
- •required revision of previous standard femoral stem
- •women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
- •life expectancy less than 5 years
研究组 & 干预措施
Minima Stem with ST-c Cup
Minima Stem with ST-c Cup
干预措施: TT cup and ST-C cup (Device)
Minima Stem with TT Cup
Minima Stem with TT Cup
干预措施: TT cup and ST-C cup (Device)
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: 3 years
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery
Harris Hip Score (HHS)
时间窗: Pre-operative, 3 months, 6 months, 1 year and 3 years
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
次要结局
- Implant stability(6 months, 1 year, 3 years, 5 years after surgery)
- Oxford Hip Score (OHS)(5 years)
- Survival Rate(5 years)
- Forgotten Joint Score (FJS)(3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery)
- Safety assessment(Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years)
- Harris Hip Score (HHS)(5 years)
- Oxford Hip Score (OHS)(Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years)