Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
研究概览
简要总结
This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral THA
- •Over 18 years of age and below 80
- •Subject is willing and able to complete required study visits and assessments
- •Subject is willing to sign the approved informed consent form
排除标准
- •Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
- •Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Subject is currently incarcerated or has impending incarceration
- •Previous hip surgery or infection on ipsilateral hip
结局指标
主要结局
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
时间窗: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Change in Gait analysis
时间窗: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements.
次要结局
- Change in Visual Analog Scale (VAS) Pain Score(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.)
- Readmission rates(3 months post-operatively)
- Change in Timed-Stair-Climb (TSC)(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)
- Change in Complication rates(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)
- Change in Timed-up-and-go (TUG)(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)
- Change in Range of Motion (ROM)(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)
- Change in EQ-5D-5L(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)
- Change in Pre-post Hgb(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.)
- Change in X-rays (AP pelvis & lateral)(This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.)