Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
试验速览
- 阶段
- 不适用
- 试验地点
- 3
- 主要终点
- Survivorship of Bone Preservation Tri-Lock femoral stem
研究概览
简要总结
This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient signed an IRB, study specific informed patient consent
- •Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
- •Patient has primary diagnosis of non-inflammatory degenerative joint disease.
- •Patient is a candidate for primary cementless total hip replacement
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) > 40 Kg/m2
- •Patient has an active or suspected infection at the time of device implantation
- •Patient is immunologically suppressed.
- •Patient requires revision surgery of a previously implanted total hip replacement
- •Patient has a known sensitivity to device materials
研究组 & 干预措施
Total Hip Arthroplasty performed via direct anterior approach
干预措施: Total Hip Arthroplasty (Procedure)
Total Hip Arthroplasty using anterolateral approach
干预措施: Total Hip Arthroplasty (Procedure)
结局指标
主要结局
Survivorship of Bone Preservation Tri-Lock femoral stem
时间窗: 2 years post-op
Survivorship will be assessed via radiographic (x-ray) analysis and need for revision surgery (if patient had femoral stem removed for any reason within the first two years after surgery).
次要结局
- TUG (timed up and go) Score(6 weeks post-op)