NCT05591859撤回不适用
Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Success rate
研究概览
简要总结
This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
- •Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
- •Subject is skeletally mature.
- •Subject is a male or non-pregnant female.
- •Subject is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •Subject has a non-Stryker retained stem at the time of study device implantation.
- •Subject has a Body Mass Index (BMI) >
- •Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- •Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
- •Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days).
- •Subject has a known sensitivity to device materials.
- •Subject is a prisoner.
研究组 & 干预措施
Restoration Anatomic Acetabular Shell
Other
干预措施: Restoration Anatomic Acetabular Shell (Device)
结局指标
主要结局
Success rate
时间窗: 10 years
Success rate is defined as no incidence of revision for aseptic loosening
次要结局
- Adverse Events(10 years)
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
Tritanium® Primary Acetabular Shell StudyArthroplasty, Replacement, HipNCT01063751Stryker Orthopaedics275
已完成
不适用
Computed Tomography (CT) Reconstruction for Axillary Lymph Node StructureInvasive Breast CancerNCT03247478Peking University160
终止
不适用
PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff TearsFull-thickness Rotator Cuff TearNCT03339492Orthofix Inc.377
已完成
1 期
Acetabular Shell Positioning Using Patient Specific InstrumentsOsteoarthritis, HipRheumatoid ArthritisAvascular NecrosisNCT01791738The Cleveland Clinic36
终止
不适用
Real Time 3D Imaging and Surrogate Bone ModelArthritisNCT02204007The Cleveland Clinic36