NCT05014113Unknown不适用
A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Harris Hip Score (HHS)
研究概览
简要总结
The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
- •Both genders
- •A diagnosis in the target hip of one or more of the following:
- •Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
- •Rheumatoid Arthritis
- •Post-traumatic arthritis
- •Fractures of femoral neck
- •Congenital or acquired deformity
- •Patient willingness to participate
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 diseases 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 prosthesis
- •Metal hypersensitivity to implant materials
- •Required revision of previous standard femoral stem
- •Age < 18 years old
- •Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:
- •significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery
- •neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- •known metabolic disorders leading to progressive bone deterioration
- •Hip replacement on the contralateral side performed within less than one year
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: Pre-operative - Month 36
Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery
次要结局
- Stability assessment of MINIMA stem(At discharge - Month 36)
- Safety assessment (adverse events)(Intra-operative - Month 36)
- Stability assessment of DELTA ST-C cup(At discharge - Month 36)
- Survival rate of the implant(Month 36)
研究者
研究点 (1)
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