Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 202
- 试验地点
- 10
- 主要终点
- Survival of the study device
研究概览
简要总结
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.
详细描述
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the Kaplan-Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to the implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 to 80 years of age, inclusive
- •Patient is skeletally mature
- •Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
- •Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •High risk for dislocation
- •Undergoing revision hip arthroplasty
- •Correction of functional deformity
- •In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
- •Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent
排除标准
- •Patient is septic, has an active infection or has osteomyelitis at the affected joint
- •Patient has significant osteoporosis as defined by treating surgeon
- •Patient has metabolic disorder(s) which may impair bone formation
- •Patient has osteomalacia
- •Patient has distant foci of infections which may spread to the implant site
- •Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
- •Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
- •Patient is undergoing simultaneous bilateral THA
- •Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery.
- •In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- •Patient is known to be pregnant
- •The patient is in the vulnerable population group, such as
- •a prisoner
- •a known alcohol or drug abuser
- •mentally incompetent or unable to understand what participation in this study entails
研究组 & 干预措施
Total Hip Arthroplasty Treatment Group
This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.
干预措施: Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners (Device)
结局指标
主要结局
Survival of the study device
时间窗: 10 years
Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.
次要结局
- Incidence of treatment-emergent Adverse Events (safety)(10 years)
- Radiographic Performance evaluating atrophy/hypertrophy at 5 years follow-up(5 Years)
- Radiographic Performance evaluating device fracture at 5 years follow-up(5 Years)
- Pain and Functional Performance - Oxford Hip Score(10 years)
- Radiographic Performance evaluating component migration at 5 years follow-up(5 Years)
- Pain and Functional Performance - Modified Harris Hip Score(10 years)
- Radiographic Performance evaluating radiolucency at 5 years follow-up(5 Years)
- Radiographic Performance evaluating osteolysis at 5 years follow-up(5 Years)
- Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)(10 Years)
- Radiographic Performance evaluating heterotopic ossification at 5 years follow-up(5 Years)