Posterior Approach Versus Lateral Approach in Osteoarthritis Patients, With Primary Total Hip Arthroplasty. The Effect on Early Physical Function, Pain, Patient Reported Outcome Measures, Gait and Muscle Weakness A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
研究概览
简要总结
The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 45-70 years, both included.
- •Patients schedule for primary cementless total hip arthroplasty.
- •Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle > 20 degrees).
排除标准
- •more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
- •Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
- •Any physical disability that prevents patients from walking 20 meters without aid.
- •The patients is not suitable for standard cementless prosthetic components.
- •Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
- •Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
- •Severe dementia.
- •Inability to read and understand Danish writing and oral instructions.
- •Do not want to participate
结局指标
主要结局
Hip Disability and Osteoarthritis Outcome Score (HOOS)-Physical Function Short form(HOOS-PS), 12 month
时间窗: Endpoint 12 month
Primary study: Hip Disability and Osteoarthritis Outcome Score (HOOS) includes five subscales: 1)Pain 2) Other symptoms 3) Activities of daily living(ADL) 4) Sport and recreation function and 5) Hip related quality of life. HOOS-Physical Function Short form (HOOS-PS) is an aggregation and shortening of the two original subscales of HOOS-ADL and Sport and Recreation. HOOS-PS is a validated instrument. HOOS has been translated to Danish. We will use HOOS-PS as primary outcome.
次要结局
- Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 12 month(Baseline, 3 month, 6 month and endpoint 12 month)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)-Hip related quality of life, 12 month(Baseline, 3 month, 6 month and endpoint 12 month)
- University of California Los Angeles activity score (UCLA), 12 month(Baseline, 3 month, 6 month and endpoint 12 month)
- 30 seconds maximal repeated unilateral knee bending, 3 month(Baseline, 3 days, 21 days and endpoint 3 month)
- Kinematic gait data, 12 month(Baseline, 3 month, and endpoint 12 month)
- EQ-5D self-rated health index -and EQ VAS scores, 12 month(Baseline, 3 month, 6 month and endpoint 12 month)
- The 20 meter walk-test (20MeWa)(Baseline, 3 days, 21 days and endpoint 3 month)
- Self-reported pain on a numerical ranking scale(NRS), 3 month(Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)-pain, 3 month(Baseline, 5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week)
- Hip Range of motion (ROM), 3 month(Baseline and endpoint 3 month)
- Limping question from Harris Hip Score(Baseline, 3 month, 6 month and endpoint 12 month)
- "Repeated chair rise"- test (RCR), 3 month(Baseline, 3 days, 21 days and endpoint 3 month)
- Gait Deviation Index(GDI), 12 month(Baseline, 3 month, and endpoint 12 month)
- Temporospatial parameters, 12 month(Baseline, 3 month, and endpoint 12 month)
- Electromyography (EMG) during walk, 12 month(Baseline, 3 month, and endpoint 12 month)
- Isometric maximal voluntary muscle contraction(MVC), 12 month(Baseline, 3 month, and endpoint 12 month)
- "Timed Up and Go"- test (TUG), 3 month(Baseline, 3 days, 21 days and endpoint 3 month)
- Opioid consumption, 3 month(Baseline, 1,2,3,4,5 days, 2, 3, 4, 6,8,10 weeks and endpoint 12 week)
研究者
Signe Rosenlund, MD, ph.d. student
MD, ph.d.-student
Odense University Hospital