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临床试验/NCT02346513
NCT02346513Unknown不适用

Serum Level of Cobalt and Chromium After Ceramic on Metal Articulation Total Hip Arthroplasty

Korea University Guro Hospital1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
228
试验地点
1
主要终点
Serum metal ion analysis

研究概览

简要总结

Primary objectives:

  1. To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion concentration) in patients that received the Ceramic on Metal arthroplasty of hip and who have well functioning primary total hip arthroplasties during short and medium- term follow up time points.
  2. To compare blood ion levels of patient that received COM arthroplasty with the blood ion levels of patient receiving non-COM standard total hip arthroplasty (a Metal on polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and medium-term follow up time points .

Secondary Objective:

  1. To determine whether these blood levels correlate with any device specific factors such as: component position, size and type, wear rate and/or patient specific factors such as gender, body mass index, age and activity level.

详细描述

Peri-prosthetic osteolysis is associated with aseptic loosening of a total hip replacement (THR). It is understood to be a biological response to wear particles, with polyethylene debris thought to be the major cause of the long-term failure.

With total hip replacement (THR) patients now being younger, more active younger, and anticipating much greater longevity, reduced bearing wear becomes increasingly important. Compared to the wear and osteolysis incidence with metal-polyethylene bearings, the historical results of alternate bearings such as metal-on-metal (MOM) and ceramic-on-ceramic (COC) generally showed much lower wear rates and osteolysis was seemingly quite rare. The laboratory wear-rates for metal-metal bearings have generally fallen into the range 1-7 mm3/million cycles (Mc) and 0.1-1 mm3/Mc for run-in and steady-state phases, respectively.

Ceramic-on-ceramic and metal-on-metal bearing surfaces are often employed for total hip replacement because of their resistance to wear. Alternative bearing surfaces such as ceramic-on-ceramic and metal-on-metal eliminate polyethylene wear. Explanted metal-on-metal articulations made of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy have been shown to have extremely low rates of linear wear, and ceramic-on-ceramic bearings even less. A ceramic-on-ceramic articulation was first implanted in 1970 in France. Long-term reports have shown excellent clinical results.

Ceramic-on-ceramic bearings have the advantage of low wear and high biocompatibility. Alumina-ceramic particles are essentially insoluble in organic media and ionisation is therefore unimportant. However, they have some limits: brittleness is a major concern for ceramic, which could lead to clinically relevant failure rates (0.004% head fracture and 0.22% liner fracture. Although Metal-on-metal (MOM) articulations have been seen as one potential solution to the problems associated with UHMWPE-induced osteolysis, metal ions present in the serum and their potential toxic effects both locally and systemically are a cause for concern.

A low wear rate is believed to be critical for extending the implant life of a prosthetic joint, and wear volumes produced by MOM articulations have been estimated to be 40-100 times lower than metal-on-polyethylene bearings. The wear of MOM prostheses is known to be highly dependent upon the materials, tribological design and finishing technique. Clinical studies of retrieved first and second-generation MOM hip prostheses have shown linear penetrations of approximately 5 μm/year. This is equivalent to a wear volume of approximately 1 mm3/year, two orders of magnitude lower than conventional polyethylene acetabular cups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has signed an informed consent to this study approved by the Institutional Review Board
  • Is not morbidly obese
  • Is clinically qualified for THA based on physical examination and medical history
  • Has non inflammatory joint disease( osteoarthritis, traumatic arthritis, avascular necrosis ,pelvic fracture, dysplastic variants)
  • Does not have a previous THA or fusion of the hip
  • Pre-operative Harris hip score was below 75 scores
  • Has follow up period that is between 1-2yr or between 2-6yr
  • Surgery was performed by minimal invasive posterior approach by the single surgeon in all groups
  • Standard postoperative care and rehabilitation protocol for both groups (care providers blinded for implant type/ or not)

排除标准

  • Diagnosis of inflammatory joint disease
  • Any current metal hardware
  • Any arthroplasty in any other joint during study follow-up period
  • Pre-operative deranged levels of serum urea, creatinine
  • Severe medical disability limiting ambulation
  • Occupational exposure to cobalt or chromium
  • If they are taking proprietary multivitamins and minerals
  • Chronic steroid or immunosuppressive therapy
  • Metabolic bone disease other than osteoporosis
  • Has plans to relocate to other geographical area before completion of study

结局指标

主要结局

Serum metal ion analysis

时间窗: 6 months

Blood sampling will be performed 2 times during follow-up outpatient clinic visits. Second sampling is performed 3 months after first sampling.

次要结局

  • Wear Measure(6 months)
  • Radiographic evaluation(6 months)
  • WOMAC score(6 months)
  • Harris Hip score(6 months)
  • UCLA activity score(6 months)
  • Number of Participants with Adverse Events(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Won Yong Shon

Professor Won Yong Shon, Department of Orthopedic Surgery, Korea University Guro Hospital, Seoul.

Korea University Guro Hospital

研究点 (1)

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