Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach.
研究概览
简要总结
The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).
详细描述
This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
- •Those presenting with primary or secondary osteoarthritis
- •Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)
排除标准
- •Pregnant women or women who plan to conceive within the year following surgery
- •Inflammatory arthritic condition
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- •Those already treated with a failed Total Hip Arthroplasty (THA)
- •Muscle contracture around the hip joint
- •Individuals who have undergone organ transplant
- •Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- •Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
- •Individuals who have had a THA on the contra-lateral side within the 6 months.
- •Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
- •Individuals requiring bilateral hip replacement
- •Individuals whose body mass index (BMI; kg/m2) >40
- •Individuals with active or suspected infection or sepsis
- •Individuals with chronic renal failure as defined by the need for dialysis
- •Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
- •History of drug and/or substance abuse
结局指标
主要结局
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach.
时间窗: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year
次要结局
- Evaluate/compare two surgical approaches (direct anterior vs. posterior): Patient improvement (subjective and objective) following THA using the HHS. Patient overall function and pain following THA using the WOMAC. Post operative radiological findings(Pre-Op, 6 weeks, 3 months, 1 year)