NCT02865447已完成不适用
A Dual Energy X-ray Absorptiometry (DXA) Evaluation of Bone Density Changes After Hip Replacement. Performance of the PROFEMUR® PRESERVE Hip Stem in Total Hip Arthroplasty, Two-Year Clinical and DXA Analysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
研究概览
简要总结
Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip joint.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, subjects must meet all of the following criteria:
- •Subject is minimum age 21 years, maximum age of 80
- •Subject is a candidate for primary THA for osteoarthritis of the hip
- •Subject is able to undergo primary elective THA procedure
- •Subject is willing and able to complete required study visits and assessments
- •Subject is willing to sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent document.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •Overt infection;
- •Distant foci of infections (which may cause hematogenous spread to the implant site);
- •Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
- •Skeletally immature (less than 21 years of age at time of surgery);
- •Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
- •Neuropathic joints;
- •Known Hepatitis or HIV infection;
- •Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- •Subjects with known osteoporosis of the affected hip
- •Subjects with prior arthroplasty of the affected hip
- •Subjects that are clinically obese (>40 body mass index [BMI])
- •Subjects with femoral dysplasia of the affected hip
- •Subjects with trochanteric osteotomy of the affected hip
- •Subject with inflammatory arthritis of the affected hip
- •Subjects currently taking, or have taken within 12 months of enrollment, bisphosphonates, parathyroid hormone (PTH), fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect BMD in a substantial way
- •Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- •Subjects with known substance abuse issues
- •Subjects who are incarcerated or have pending incarceration
结局指标
主要结局
Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
时间窗: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
次要结局
- Hip functional outcomes will be assessed using the Harris Hip score.(Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative)
- Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem.(6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative)
- Implant survivorship of the femoral stem will be calculated.(1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative)
- Rate of complications will be assessed.(Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative)
- Hip functional outcomes will be assessed using the Forgotten Joint Score.(6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative)
研究者
研究点 (1)
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