Supercapsular Percutaneously-Assisted Total Hip (SuperPATH®) Versus Conventional Posterior Approach for Total Hip Arthroplasty: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Functional Outcomes TUG
研究概览
简要总结
The SuperPATH approach is a minimally invasive approach for total hip arthroplasty. This project randomized patients to the SuperPath versus posterior approach. Outcomes examined included functional, VAS pain, narcotic utilization, perioperative outcomes, and radiographic component positions. Participants were followed for 2 years. The aim was to examine if the SuperPATH approach provided significant advantages over the posterior approach on functional testing or return to work for patients.
详细描述
Background: The Supercapsular Percutaneously-Assisted Total Hip (SuperPATH) approach is a minimally invasive approach for total hip arthroplasty. It has been reported to show earlier mobilization, better gait kinematics, and short hospital length of stay. Our primary objective was to compare functional tests of timed up and go and timed stair climb preoperatively, at discharge, 2 weeks, and 6 weeks postoperatively. Secondary objectives included the return to function in weeks, Oxford hip scores, visual analog scale, narcotic utilization, perioperative outcomes, and radiographic component positions.
Methods: Forty-six patients were randomized into two groups on the surgery day: the SuperPATH group (25 patients) and the Posterior group (20 patients). Outcomes examined included functional, VAS pain, narcotic utilization, perioperative outcomes, and radiographic component positions.
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
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- •Inflammatory degenerative joint disease including rheumatoid arthritis;
- •Correction of functional deformity.
- •Subject is skeletally mature (21 years of age or older);
- •Subject is a candidate to be implanted with the specified combination of components;
- •Subject is willing and able to complete required study visits and assessments;
- •Subject plans to be available through the follow-up visits;
- •Subject is willing to sign the approved informed consent document.
- •Subjects with a previous THA in the contralateral hip are eligible for enrollment provided it has been at least 1 year since the contralateral THA and the contralateral THA is asymptomatic and not pending revision. Simultaneous bilateral THA subjects will not be permitted to enroll.
排除标准
- •Subject has overt infection or distant foci of infections;
- •Subject has rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
- •Subject with inadequate neuromuscular status (e.g. prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
- •Subject has a neuropathic joints;
- •Subject has hepatitis or HIV infection;
- •Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
- •Subject is currently enrolled in another clinical investigation that could affect the endpoints of this study;
- •Subject is unwilling or unable to sign the informed consent document;
- •Subject has documented substance abuse issues;
- •Subject has a body mass index (BMI) of greater than 40;
研究组 & 干预措施
Posterior Approach
This is the traditional THA surgical approach used.
Superpath
This is a minimally invasive surgical approach.
干预措施: Superpath Approach (Procedure)
结局指标
主要结局
Functional Outcomes TUG
时间窗: 6 weeks
Timed up and go test
Functional Outcomes TSC
时间窗: 6 weeks
Timed stair climb
次要结局
- Pain Score(1 month)
- Subjective Measure(3 months)
研究者
Dr. Gavin Wood
Principal Investigator
Queen's University