NCT00962351已完成不适用
Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- cobalt, chromium, and titanium ion levels in blood and urine
研究概览
简要总结
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cementless primary total hip replacement
- •Receiving acetabular cup of 52mm or greater
- •Preoperative level of function and pain same as for conventional hip replacement
- •Likelihood of obtaining relief of pain and improved function
- •Full skeletal maturity
- •Ability to follow instructions
- •Good general health
- •Willing to return for follow-up evaluations
- •X-ray evaluation confirming the presence of NIDJD
- •Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants
排除标准
- •Age less than 40 years or greater than 80 years at time of surgery
- •Patients templated to receive an acetabular component smaller than 52mm in diameter
- •Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- •Previous girdlestone procedure or surgical fusion of the hip to be operated
- •Acute femoral neck fracture
- •Above knee amputation of the contralateral and/or ipsilateral leg
- •Patients with a diagnosis of inflammatory degenerative arthritis
- •Skeletally immature
- •Evidence of active infections that may spread to other areas of the body
- •The presence of a highly communicable disease that may limit follow-up
- •Presence of known active metastatic or neoplastic disease
- •Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
- •Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
- •Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
- •Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- •Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
- •Any steroid therapy, local or systemic, within three months prior to surgery
- •Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
- •Patient has known allergies to metal, e.g., jewelry
- •Any patient not meeting all radiographic and clinical parameters for inclusion
结局指标
主要结局
cobalt, chromium, and titanium ion levels in blood and urine
时间窗: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
次要结局
- Hip function(Pre-op, 6 months,1 year, 2 years, 3 years, 5 years)
- Durability(6 months, 1 year, 2 years, 3 years, 5 years)
研究者
C. Anderson Engh, Jr., MD
Orthopaedic Surgeon
Anderson Orthopaedic Research Institute
研究点 (4)
Loading locations...
相似试验
撤回
不适用
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip ArthroplastyHip ReplacementHip ImplantTotal Hip ArthroplastyOrthopaedic SurgeryNCT00883805Northwell Health
终止
不适用
Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip ResurfacingOsteoarthritis, HipNCT04585022Hvidovre University Hospital75
终止
4 期
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal BearingCollagen DisordersOsteoarthritisCongenital Hip DysplasiaSlipped Capital Femoral EpiphysisAvascular NecrosisPost-traumatic ArthritisNCT00873444DePuy International5
已完成
不适用
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip ArthroplastyTraumatic ArthritisRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT00757354Zimmer Biomet77
终止
不适用
Metal Ion Serum Concentrations in Patients With Total Hip ReplacementsOsteoarthritisNCT00156598The University of Texas Health Science Center at San Antonio5