NCT06108934招募中不适用
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Implant survivorship
研究概览
简要总结
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery.
It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.
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
- •The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
- •Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
- •The patient is a candidate for a primary cementless THA.
- •Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
排除标准
- •Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
- •Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
- •Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.)
- •Requires revision THA or hip fusion to the affected joint.
- •Has known sensitivity to device materials.
- •Any involvement in an active Workers' Compensation investigation
结局指标
主要结局
Implant survivorship
时间窗: 2 years post-operatively
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
次要结局
- Hip Disability and Osteoarthritis Outcome Score (HOOS-12).(Pre-operatively and 6 months, 12 months and 2 years post-operatively)
- Hip and lower back pain VAS(Pre-operatively and 6 months, 12 months and 2 years post-operatively)
- EQ-5D-5L(Pre-operatively and 6 months, 12 months and 2 years post-operatively)
- Oxford Hip Score(Pre-operatively and 6 months, 12 months and 2 years post-operatively)
- Femoral fracture(2 years post-operatively)
- Forgotten Joint Score (FJS)(Pre-operatively and 6 months, 12 months and 2 years post-operatively)
- Complications(Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.)
- Mortality(1 and 2 years post-operatively)
- CPR for stem loosening(2 years post-operatively)
研究者
研究点 (2)
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