Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Implant Survival
研究概览
简要总结
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
详细描述
The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip
- •System due to at least one of the following indications:
- •Osteoarthritis
- •Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants
- •Avascular Necrosis with sufficient bone stock for standard primary THA implants
- •Post-traumatic Arthritis
- •Secondary arthritis due to congenital hip dysplasia
- •Willing and able to provide written informed consent for participation in the study.
- •Aged 18 - 80 years.
- •Able (in the Investigators opinion) and willing to comply with all study requirements and complete all study visits
排除标准
- •The potential participant should be excluded from enrollment if any of the following exist:
- •Body mass index ≥ 40
- •History of other orthopaedic surgery within 6 months prior to the index surgery that, in the investigator's opinion, could affect the recovery of the index THA
- •History of pyogenic arthritis in the surgical hip joint
- •Active or suspected infection in or around the surgical hip joint
- •A neurological disorder that, in the investigator's opinion, could affect lower extremity function and recovery from the index THA
- •The potential participant is incarcerated
- •Prior fusion to the index surgical hip joint
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •9 . Any other contraindication to THA listed in the Entrada™ Hip Stem Labelling or Instructions for Use.
结局指标
主要结局
Implant Survival
时间窗: 5 - 10-year follow-up
Implant survival based on removal or intended removal of any component of Entrada Hip Sys @five years follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction, the Patient-Reported Outcomes Measurement Information System Global Health Assessment, the UCLA Activity Rating Scale. Effectiveness will be assessed by achieving minimal clinically important difference (MCID) in HOOS JR and UCLA Activity scores. Hung et al. recently reported MCID of HOOS JR to be 19.68 units in an adult recon pop. The MCID for UCLA activity score has been reported to be 0.92 units.minimal detectable change for the PROMIS Global physical and mental health measures will be assessed using one-half of the standard dev between the pre and last post change score. MCID for numeric pain scale will be assessed as a 2 unit change in pain. HOOS, JR score ranges from 1-100 where 0 = total hip disability 100 = perfect hip health.
次要结局
- Implant Survival(2 - 10 year follow-up)
- Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR)(2 - 10-year follow-up)
- PROMIS Global Health Assessment (Physical health, mental health and numeric pain score)(2 - 10-year follow-up)
- UCLA Activity Rating Scale(2 - 10-year follow-up)
- Radiographic Outcomes(2 - 10-year follow-up)
- Patient Satisfaction(2 - 10-year follow-up)
- Clinical Outcomes(2 - 10-year follow-up)