Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 8
- 主要终点
- Component Revisions at 3 Years Postoperative
研究概览
简要总结
R3 Delta Post-Approval Study U.S.
详细描述
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-75 years old and he/she is skeletally mature
- •Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
- •Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
- •Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
- •Patient has consented to participating in the study by signing the IRB/EC approved informed consent form
排除标准
- •Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
- •Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
- •Patients with active joint infections or chronic systemic infection
- •Obese patients where obesity is defined as BMI ≥ 40
- •Skeletal immaturity
- •Known allergy to implant materials
结局指标
主要结局
Component Revisions at 3 Years Postoperative
时间窗: 3 Years Postoperative
Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.
Overall Study Success at 3 Years Postoperative
时间窗: 3 Years Postoperative
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
时间窗: 3 Years postoperative
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as "Success" or "Failure" with success defined as a mHHS that is greater than or equal to 80 points.
Overall Radiographic Success at 3 Years Postoperative
时间窗: 3 Years Postoperative
Number of participants with overall radiographic success identified as "Success" or "Failure" where success indicated all of the following: * No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline * No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score
Number of Participants With Absence of Radiolucency at 3 Years Postoperative
时间窗: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
时间窗: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
时间窗: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.
次要结局
- Implant Survivorship Kaplan-Meier Estimate(Postoperatively, up to 3 years)
- Modified Hip Harris Score (mHHS)(Preoperative, 3 months, 1 year, 2 years, 3 years)
- Radiographic Findings: Number of Participants With Absence of Radiolucency(3 months, 1 year, 2 years)
- Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration(3 months, 1 year, 2 years)
- Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes(3 months, 1 year, and 2 years)