NL-OMON53064招募中不适用
Zimmer Maxera acetabular system in total hip arthroplasty: a multi-center, prospective, non-controlled post marktet clinical follow-up study - Maxera study
Zimmer Biomet GmbH0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is 18 to 75 years of age, inclusive.
- •Patient is skeletally mature.
- •Patient qualifies for primary unilateral or simultaneous bilateral total hip
- •arthroplasty
- •(THA) based on physical exam and medical history including at least one of the
- •o Osteoarthritis
- •o Avascular necrosis (AVN)
- •o Inflammatory arthritis
- •o Rheumatoid arthritis with adequate bone quality
- •o Post-traumatic arthritis
- •o Congenital hip dysplasia.
- •Patient has no history of previous total hip replacement or arthrodesis of
- •the affected hip
- •Patient has a Harris Hip Score <70 in the affected hip and a Harris Hip pain
- •moderate, marked, or disabled.
- •Patient is willing and able to provide written informed consent.
- •Patient is willing and able to cooperate in the required post-operative
- •Patient is willing and able to complete scheduled follow-up evaluations as
- •described in
- •the Informed Consent.
排除标准
- •The patient is:
- •o A prisoner
- •o Mentally incompetent or unable to understand what participation in the study
- •o A known alcohol or drug abuser
- •o Anticipated to be non-compliant
- •The patient has a neuromuscular disorder, vascular disorder or other
- •condition that
- •could contribute to prosthesis instability, prosthesis fixation failure, or
- •complications in
- •postoperative care.
- •The patient has local bone tumors and/or cysts in the portion of bone to be
- •retained in
- •the operative hip that could inhibit implant fixation.
- •The patient has insufficient bone stock or poor bone quality to fix the
- •component. Insufficient
- •bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis),
- •cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be
- •to assess the presence of adequate bone stock.
- •The patient has rapid disease progression as obvious by joint destruction or
- •bone absorption
- •seen on x-ray.
- •The patient has osteoradionecrosis in the affected hip.
- •The patient has a neuromuscular condition in the ipsilateral or contralateral
- •affects lower limb function.
- •The patient has loss of abductor musculature in the affected hip.
- •The patient has a vascular (large and small vessel disease) insufficiency.
- •The patient has had previous prosthetic hip replacement device (any type,
- •surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be
- •The patient has had previous girdlestone procedure (resection arthroplasty)
- •or surgical
- •fusion of the hip to be operated.
- •Emilie Rohmer, 11.05.2012, Rev. 0 page 17 of 57
- •F WT.30.0108-1 Effective Date 21. Okt. 2010
- •Clinical Investigation Plan Revision 0
- •The patient has an acute femoral neck fracture in the operative hip.
- •The patient has had a procedure on the operative hip in the last 6 months
- •(i.e. arthroscopy,
- •ORIF femoral neck fracture, etc).
- •The patient has undergone a total hip replacement, endoprosthesis, or surface
- •arthroplasty
- •of the contralateral (opposite side) hip within the past 6 months regardless of
- •whether the previous hip was enrolled in this clinical study.
- •The patient has a moderate to severe limb length discrepancy greater than 3.2
- •The patient has an active, old or remote infection in or about the affected
- •hip joint or an
- •infection distant from the hip joint that may spread to the hip hematogenously.
- •The patient has poor skin coverage around the affected hip joint.
- •The patient has a diagnosed systemic disease that could affect his/her safety
- •study outcome.
- •The patient is currently receiving, or within the past three months, has
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