Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DEXA Analysis of BMD at Preoperative Visit
研究概览
简要总结
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.
详细描述
The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has hip disease that requires a total hip arthroplasty.
- •Patient is willing to consent to participate in the study.
- •Patient plans to be available for the study duration.
- •Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
排除标准
- •Patient known to have insufficient bone stock.
- •Patient has had major non-arthroscopic surgery to the study hip.
- •Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- •Patient has a known sensitivity to materials in the device.
结局指标
主要结局
DEXA Analysis of BMD at Preoperative Visit
时间窗: Preoperative
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
DEXA Analysis of BMD at 6 Months
时间窗: 6 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
DEXA Analysis of BMD at 1 Year
时间窗: 1 Year
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
DEXA Analysis of BMD at 2 Years
时间窗: 2 Year
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
DEXA Analysis of BMD at 3 Months
时间窗: 3 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
次要结局
- Baseline Harris Hip Score (HHS) at Preoperative Visit(Preoperative)
- Radiographic Assessment at 3 Month Visit (Yes/No Components)(3 Months)
- Radiographic Assessment at Discharge Visit(Discharge)
- Harris Hip Score (HHS) at 3 Month Visit(3 Month)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit(5 Years)
- Radiographic Assessment at 3 Month Visit(3 Months)
- Radiographic Assessment at 5 Year Visit(5 Year)
- Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)(3 Months)
- Harris Hip Score (HHS) at 6 Month Visit(6 Months)
- Harris Hip Score (HHS) at 5 Year Visit(5 Year)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit(Preoperative)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit(2 Years)
- Harris Hip Score (HHS) at 2 Year Visit(2 Years)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit(6 Months)
- Radiographic Assessment at 5 Year Visit (Yes/No Components)(5 Year)
- Radiographic Assessment at 1 Year Visit(1 Year)
- Harris Hip Score (HHS) at 1 Year Visit(1 Year)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit(3 Months)
- Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit(1 Year)
- Radiographic Assessment at 1 Year Visit (Yes/No Components)(1 Year)
- Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)(Discharge)
- Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)(1 Year)
- Radiographic Assessment at Preoperative Visit (Yes/No Components)(Discharge)
- Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)(5 Years)