A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- Difference in osteolytic volume at 5 years postoperatively measured by CT scan.
研究概览
简要总结
The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS) and safety.
In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.
详细描述
DESIGN: Prospective 3 Arm Randomized controlled trial.
PURPOSE:To compare three commonly used contemporary bearings in Total Hip Arthroplasty (THA). In addition, to evaluate the safety and effectiveness of the G7 Cups and Echo BiMetric Stem in THA.
OUTCOME MEASURES: Osteolysis, clinical outcomes, patient satisfaction, intraoperative/surgical data, implant positioning, survivor ship, and adverse events.
POPULATION: 360 hips (240 will have CT scan for analysis of osteolysis).
ELIGIBILITY: Patients who meet inclusion and exclusion criteria defined in this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is 18 to 75 years of age, inclusive.
- •Patients determined to be suitable for uncemented fixation by investigator
- •Patient is skeletally mature.
- •Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
- •Osteoarthritis (OA)
- •Developmental Dysplasia without subluxation
- •Patient is willing and able to provide written informed consent.
- •Patient is willing and able to cooperate in the required post-operative therapy.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
排除标准
- •The patient is:
- •A prisoner
- •Mentally incompetent or unable to understand what participation in the study entails
- •A known alcohol or drug abuser
- •Anticipated to be non-compliant.
- •The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- •The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- •The patient is known to be pregnant.
- •The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
- •The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
- •The patient has had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
- •The patient has insufficient bone stock to fix the component. Insufficient bone stock exists (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation.
- •Estimated cup size smaller than 48 or stem size smaller than 7
- •The patient has known local bone tumors in the operative hip.
研究组 & 干预措施
G7 MoP (Arcom XL) + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive an Arcom Xl liner and a metal head
干预措施: Hip Arthroplasty (Procedure)
G7 MoP (E1) + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and will be operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive an E1 liner and a metal head.
干预措施: Hip Arthroplasty (Procedure)
G7 CoC + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive a ceramic liner and a ceramic head
干预措施: Hip Arthroplasty (Procedure)
结局指标
主要结局
Difference in osteolytic volume at 5 years postoperatively measured by CT scan.
时间窗: 5 years
CT scan will be performed on 240 of the 360 patients post operatively and at 5 years follow up
次要结局
- Implant positioning(Immediately postoperative,1,2,5,7 and 10 year follow up)
- Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.(3 months, 1,2,5,7 and 10 year follow up)
- Pain Assessment(3 months, 1,2,5,7,10 years)
- Physical activity level(3 months, 1,2,5,7,10 years)
- Hip specific clinical patient outcome measure(3 months, 1,2,5,7,10 years)
- Subjective satisfaction(3 months, 1,2,5,7 and 10 year follow up)
- Safety and survivorship(Continously throughout the study until 10 years FU)
- Squeaking evaluation(3 months, 1,2,5,7,10 years)
- Health related quality of life(3 months, 1,2,5,7,10 years)