NCT00604734已完成不适用
A Prospective Clinical Study On A Total Hip Resurfacing System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
研究概览
简要总结
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
详细描述
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
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
- •Patients with a preoperative Total Harris Hip Score of < 70
- •Conservative treatment has proven unsuccessful
- •Primary hip surgery
- •Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- •Osteoarthritis
- •Avascular necrosis
- •Legg Perthes
- •Rheumatoid Arthritis
- •Juvenile Rheumatoid Arthritis
- •Systemic Lupus Erythematosus
- •Developmental Dysplasia, which does not prevent stable acetabular reconstruction
- •Post traumatic arthritis S. Patients at least 18 years of age
- •Patients of all races and gender
- •Patients who are able to follow post-operative care instructions
- •Patients who are willing and able to return for scheduled follow-up evaluations
- •Patient has signed the IRB approved Informed Consent Form
排除标准
- •Patients with a preoperative Total Harris Hip Score of > 70
- •Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- •Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- •Developmental dysplasla, which prevents stable acetabular reconstruction
- •Patients with previous Girdlestone procedures
- •Patients with above knee amputation of the contralateral and/or ipsilateral leg
- •Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
- •Active or suspected systemic or localized Infection
- •Parkinson's or Alzheimer's Disease
- •Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
- •Patients less than 18 years of age
- •Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
- •Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
- •Patients with a "fused"hip
- •Patients with metal allergy or hypersensitivity
- •Participation in a study of any investigational product (drug or device) within the past 12 months
- •Prisoners,known drug or alcohol abuser,or mentally incompetent individuals
- •Systemic steroids within 6 months
- •Patients with a known malignancy
- •Patients who are pregnant
研究组 & 干预措施
ReCap
Other
ReCap Total Hip Resurfacing System
干预措施: ReCap Total Hip Resurfacing System (Device)
结局指标
主要结局
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
时间窗: 2 years postoperative
次要结局
- Complications(Anytime)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Prospective Clinical Study On A Total Hip Resurfacing SystemArthritisAvascular NecrosisNCT00603395St. Anna Ziekenhuis, Geldrop, Netherlands298
撤回
不适用
Retrospective Data Review of ReCap Total Hip ResurfacingOsteoarthritis of the HipNCT00758329Zimmer Biomet
终止
不适用
ReCap Total Hip Resurfacing Prospective Data CollectionArthritisNCT00758472Zimmer Biomet82
已完成
3 期
Durom(R) Hip Resurfacing System Multicenter TrialAdvanced Hip DiseaseNCT00746616Zimmer Biomet40
已完成
不适用
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction PairHip ReplacementPrimary, Secondary or Post-traumatic OsteoarthrosisFemur Head NecrosisCongenital DislocationsNCT02062437Stryker Trauma and Extremities132