Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
研究概览
简要总结
The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).
详细描述
The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.
The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able to or capable of providing consent to participate in the clinical investigation.
- •Subject is between the ages of 20-75 years, inclusive.
- •Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
- •Subject has sufficient bone stock for the hip replacement device.
- •Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
排除标准
- •Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
- •Subject has had previous surgery on the affected hip.
- •Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
研究组 & 干预措施
Anterior Approach Total Hip
Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach
干预措施: Anterior Approach / Posterior Approach (Procedure)
Posterior Approach Total Hip
The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach.
干预措施: Anterior versus Posterior Approach for total hip replacement (Procedure)
结局指标
主要结局
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
时间窗: 5 years
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
次要结局
未报告次要终点
研究者
William Barrett, M.D.
William Barrett,M.D,
Barrett, William, M.D.