Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 313
- 试验地点
- 22
- 主要终点
- Survival Rate
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
详细描述
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
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 subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
- •The subject is skeletally mature
- •The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
- •The subject is a candidate for a primary or revision cementless THA.
- •The subject is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •The subject is pregnant or breastfeeding
- •The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
- •The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •The subject has a known sensitivity to device materials.
- •The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
- •The subject is a prisoner.
研究组 & 干预措施
Insignia uncemented Hip Stem
The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside.
Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures.
干预措施: Insignia uncemented Hip Stem (Device)
结局指标
主要结局
Survival Rate
时间窗: 10 years
Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
Harris Hip Score (HHS)
时间窗: 10 Years
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
次要结局
- Harris Hip Score (HHS)(pre-op, 6 week, 1,2,5 and 7 years)
- EQ-5D - Visual analogue scale (VAS)(pre-op, 6 week, 1,2,3, 4,5,7 and 10 years)
- Survival Rate(2 years)
- EQ-5D - Descriptive System(pre-op, 6 week, 1,2,3, 4,5,7 and 10 years)