Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 211
- 试验地点
- 6
- 主要终点
- Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form
研究概览
简要总结
This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique.
详细描述
Objective: The primary objective is to evaluate health related quality of life (HRQoL) after THA using the DSA compared to the golden standard PLA in patients with incapacitating hip osteoarthritis after two weeks. The secondary objectives are divided into 1) long-term HRQoL evaluation, 2) physical performance, 3) radiologic muscle atrophy and component placement of the THA, 4) validation of a new metal artifact reduction technique for CT, and 5) relationship urinary incontinence and muscle atrophy.
Study design: Multicenter, prospective, double blinded, randomized controlled intervention study in which the used operation method is not shared with the patient until one year after surgery and in which the study researcher is also blinded.
Study population: A total of 211 men and women, age ≥ 18 years, with symptomatic hip osteoarthritis in whom THA is indicated.
Intervention (if applicable): For this randomized controlled trial (RCT), patients will be randomly allocated in one of two groups: one group receives THA by using PLA, the other group receives THA by using DSA.
Main study parameters/endpoints: As primary outcome specifically the Hip Disability and Osteoarthritis Outcome Score- Physical Function Short Form (HOOS-PS) is used for the short-term HRQoL.
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, Investigator)
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
- •Has symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA) is indicated, diagnosed by both physical examination and pelvic/hip X-ray
- •Has signed informed consent
- •Is ageing 18 years or older at time of study entry
- •Is competent and able to participate in follow-up
排除标准
- •Previous ipsilateral hip surgery
- •BMI >35 kg/m2
- •Contralateral incapacitating coxarthrosis, diagnosed by both physical examination and pelvic/hip X-ray
- •Neurological conditions influencing walking pattern
- •Inability to walk without walking aid preoperatively
- •Rheumatoid arthritis (RA)
- •Severe hip dysplasia
- •Cognitive impairment
- •Malignancies or metastases involving the hip joint or the nearby soft tissues
- •Inability to speak and write Dutch language
结局指标
主要结局
Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form
时间窗: pre-operatively and 2 weeks, 6 weeks, 3months and 12 months postoperatively
Evaluation symptoms and shortcomings in patients with hip complaints, 0-100 points, in which a higher score indicates less complaints
次要结局
- 40 meter self-paced walk test for hip osteoarthritis(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Stair climb test(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Muscle atrophy by using Computer Tomography (CT) scanner(pre-operatively and 12 months postoperatively)
- Incontinence Severity Index (ISI)(pre-operatively and 6 weeks and 12 months postoperatively)
- Urinary Distress Inventory, Short Form (UDI-6)(pre-operatively and 6 weeks and 12 months postoperatively)
- Patient Global Impression of Severity (PGIS)(pre-operatively and 6 weeks and 12 months postoperatively)
- Incontinence Impact Questionnaire Short Form (IIQ-7)(pre-operatively and 6 weeks and 12 months postoperatively)
- Incontinence after Total Hip Arthroplasty(6 weeks and 12 months postoperatively)
- Short Form-12 (SF-12)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR)(pre-operatively and 12 months postoperatively)
- Postoperative cup position on Computer Tomography (CT) image(12 months postoperatively)
- Comparing definite cup position with preoperative planned cup position(pre- operatively and 12 months postoperatively)
- Comparing definite component position with surgeon's perioperative estimation of component position(direct postoperative and 12 months postoperatively)
- image diagnostic confidence(pre- operatively and 12 months postoperatively)
- metal artifacts on images(pre- operatively and 12 months postoperatively)
- overall image quality(pre- operatively and 12 months postoperatively)
- Hip disability and Osteoarthritis Outcome Score (HOOS)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Timed Up and Go test (TUG test)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Numeric Rating Scale (NRS)(pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively)
- Short Form-12 (SF-12)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Hip disability and Osteoarthritis Outcome Score (HOOS)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Euro Quality of Life (EQ-5D)(pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively)
- Global Rating of Change scale(pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively)
- Timed Up and Go test (TUG test)(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- 40 meter self-paced walk test for hip osteoarthritis(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Stair climb test(pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively)
- Muscle atrophy by using Computer Tomography (CT) scanner(pre-operatively and 12 months postoperatively)
- Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR)(pre-operatively and 12 months postoperatively)
- image diagnostic confidence(pre- operatively and 12 months postoperatively)
- Incontinence Severity Index (ISI)(pre-operatively and 6 weeks and 12 months postoperatively)
- Incontinence Impact Questionnaire Short Form (IIQ-7)(pre-operatively and 6 weeks and 12 months postoperatively)
- Postoperative cup position on Computer Tomography (CT) image(12 months postoperatively)
- Comparing definite cup position with preoperative planned cup position(pre- operatively and 12 months postoperatively)
- Comparing definite component position with surgeon's perioperative estimation of component position(direct postoperative and 12 months postoperatively)
- overall image quality(pre- operatively and 12 months postoperatively)
- metal artifacts on images(pre- operatively and 12 months postoperatively)
- Urinary Distress Inventory, Short Form (UDI-6)(pre-operatively and 6 weeks and 12 months postoperatively)
- Patient Global Impression of Severity (PGIS)(pre-operatively and 6 weeks and 12 months postoperatively)
- Incontinence after Total Hip Arthroplasty(6 weeks and 12 months postoperatively)