Post-market Clinical Follow-up Study of the G7 Freedom Constrained Neutral Liner and G7 Neutral +5mm Liner in Primary and Revision Total Hip Arthroplasty (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
研究概览
简要总结
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
详细描述
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or older and skeletally mature
- •Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
- •Noninflammatory degenerative joint disease including:
- •Osteoarthritis
- •Avascular necrosis
- •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
- •High risk of dislocation due to:
- •History of prior dislocation
- •Bone loss
- •Joint or soft tissue laxity
- •Neuromuscular disease
- •Intraoperative instability
- •Revision procedures where other treatment or devices have failed
排除标准
- •Off-label use
- •Infection and/or distant foci of infections which may spread to the implant site
- •Osteomyelitis
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy or neuromuscular disease
- •Patient is known to be pregnant or nursing
- •Patient is a prisoner
- •Patient is a known alcohol or drug abuser
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- •Patient is unwilling to sign an informed consent
结局指标
主要结局
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
时间窗: Out to five years
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
次要结局
- Device Performance and Benefits evaluated through the Oxford Hip Score(Out to five years)