NCT00698347终止不适用
A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 249
- 主要终点
- Harris Hip Score
研究概览
简要总结
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System
详细描述
This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.
This product was FDA cleared in 2004.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis
- •Rheumatoid Arthritis
- •Correction of Functional Deformity
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Revision of previously failed total hip arthroplasty
排除标准
- •Absolute contraindications include:
- •Infection, Sepsis, and Osteomyelitis
- •Relative contraindications include:
- •Uncooperative patient or patient with neurologic disorders that are incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease
结局指标
主要结局
Harris Hip Score
时间窗: 10 years
次要结局
- Incidence of revisions, removals, and/or complications(Any time)
- X-Rays(10 years)
研究者
相似试验
撤回
不适用
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder SystemsHumeral FracturesRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT00699270Biomet Orthopedics, LLC
已完成
不适用
A Clinical Investigation of the Balance® Microplasty™ Hip SystemOsteoarthritis, HipRheumatoid ArthritisAvascular NecrosisNCT00699088Biomet Orthopedics, LLC70
已完成
不适用
A Clinical Investigation of the Taperloc® Microplasty™ Hip SystemRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT00699309Biomet Orthopedics, LLC98
进行中（未招募）
不适用
A Clinical Investigation of the Vanguard™ Complete Knee SystemTraumatic ArthritisLower Limb DeformityComplications, ArthroplastyRheumatoid ArthritisOsteoarthritisNCT00698854Zimmer Biomet600
终止
不适用
A Clinical Investigation of the Oxford® Partial Knee SystemOsteoarthritisNCT00699257Biomet Orthopedics, LLC85