Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation
研究概览
简要总结
This is a prospective randomized control trial comparing two collared and collarless femoral implants used in primary total hip arthroplasty. The specific aims of this trial are to:
SA1: Prospectively assess clinical outcomes in patients undergoing primary total hip arthroplasty with a collared versus collarless femoral stem of the same design.
SA2: Evaluate serial radiographs to quantify differences in subsidence between collared and collarless implant groups.
SA3: Report and compare incidence rates of intraoperative and postoperative periprosthetic fractures and aseptic loosening following primary total hip arthroplasty with use of either a collared or collarless stem.
Hypothesis: The addition of a collar to the same designed triple-taper primary hip stem will lead to a reduction in subsidence and incidence of perioperative and periprosthetic femur fractures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years old) scheduled for primary, uncemented THA using a cementless femoral stem
- •Diagnosis of primary osteoarthritis or other non-inflammatory degenerative joint disease.
- •Ability and willingness to comply with study procedures and follow-up schedule.
- •Ability to provide written informed consent
排除标准
- •Patients not indicated for a cementless THA
- •Prior surgery on the ipsilateral hip (e.g., prior THA, internal fixation, osteotomy)
- •Use of cemented or hybrid femoral components.
- •Revision THA or conversion THA
- •Active or prior infection of the hip joint.
- •Severe osteoporosis (T-score ≤ -2.5) or known metabolic bone disease.
- •Inability to complete follow-up or anticipated relocation out of the area.
研究组 & 干预措施
Collard stem
干预措施: Collared Femoral Stem (Other)
Collarless stem
干预措施: Collarless Femoral Stem (Other)
结局指标
主要结局
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation
时间窗: 6 weeks, 6 months, and 1 year post operation
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation used radiographic evidence.
次要结局
未报告次要终点