Arthroscopic Surgical Procedures Versus Sham Surgery for Patients with Femoroacetabular Impingement And/or Labral Tears. a Multicentre, International, Double-blinded Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- International Hip Outcome Tool (IHOT-33)
研究概览
简要总结
The primary aim of this study is to determine the efficacy of hip arthroscopic surgery compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and radiological findings related to impingement (FAI) and/or labral tears using a randomized controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1 year follow-up)).
Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33) after 1 year and at further (HIPARTI Study).
The secondary aim of this study is to establish modifiable risk factors associated with pain, function, work participation and quality of life over 1 year in people aged 18-50 years with hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate paper will be published with this main aim for the HARP Study) Long-term follow-ups for HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims and separate papers).
详细描述
This is a multicenter, international, assessor and patient blinded clinical RCT with two groups (primary aim). the HIPARTI Study with The design of this trial conforms to the SPIRIT guidelines.
All patients with hip pain eligible for hip arthroscopy in our routine care pathways will be identified in our outpatient clinics. Consultant orthopedic surgeons will determine a patient's eligibility for the study (based on inclusion and exclusion criteria for the study) and members of their team introduce the study to the patients and refer them to the research coordinators for further information. Patients will be provided with oral and written information about the study and be introduced to our consent form. If interest continues the patient will be provided with further information and arrangements will be made for a baseline appointment for assessment and consenting.
The baseline assessment appointments will occur within one month of the initial approach. At the baseline appointment patients will meet with the research coordinator and the independent research assistant/tester (physical therapist) who will be the blinded tester. Patients will return their signed informed consent form and baseline questions completed. Those who are not willing to participate in the RCT (HIPARTI Study), will be asked if interested in being included in a prospective longitudinal cohort study including similar baseline and follow-up tests as those in the RCT (this will be the HARP Study with separate papers published). All patients in the HARP Study will undergo hip arthroscopy surgery. The Australian site will include most of their patients in the HARP Study, since the majority of orthopedic surgeons working privately will not participate in the HIPARTI Study. Data collection will be performed electronically for both the HIPARTI and the HARP Studies entering all data in the approved Checkware system (www.checkware.no).
Each collaborating center will apply to the ethical committee and the Data Inspectorate in each country/institution. Approval was confirmed for Oslo University Hospital (HIPARTI) and Australia (HARP Study) in January 2016.
Randomization (HIPARTI) will occur prior to surgery, after final eligibility is confirmed. Randomizations will be performed centrally using an automated computer generated system. Block randomization and stratification for each center will be performed.
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, Outcomes Assessor)
盲法说明
This is only for the RCT Study - the double-blinded study. The HARP study consists of only a prospective longitudinal study With same outcome measure and follow-ups; hence, given 3 arms. The below "Allocation" and "Number of Subjects" is ONLY for the RCT part of the study
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hip pain during daily and/or spor t ing activities;
- •intra-articular hip pain with radiological signs of FAI and/or labral tears eligible for hip arthroscopy (to be determined in a pragmatic fashion by the surgeon based on clinical examination and imaging
- •the patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures
排除标准
- •pain that is not confirmed by physical examination of the hip
- •evidence of preexisting osteoarthritis, defined as Tonnis grade >1, or less than 3mm superior joint space width on AP pelvic radiograph
- •center edge angle on radiograph <25°; (v) previous known hip pathology such as Perthes' disease, slipped upper femoral epiphysis or avascular necrosis
- •previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture
- •previous hip surgery
- •medical conditions complicating surgery (ASA 3); (ix) inflammatory joint disease (RA, Bechterew etc)
- •physical inability to undertake testing procedures
- •expected lack of compliance such as cognitive impairment, drug abuse or similar;
- •inability to understand the written and spoken language of the treatment centre;
- •contra-indications to placebo surgery, which will include large loose body, chondral flap >1cm2 detached at 3 sides, complete labral radial flap tear and labral bucket-handle tear with complete avulsion >1.5cm long
结局指标
主要结局
International Hip Outcome Tool (IHOT-33)
时间窗: Baseline, 6,12 an 24 months follow-ups - 1 year follow-up is main outcome
Patient-reported outcome measure (PRO)
次要结局
- Expectations of surgery(Baseline)
- HOOS - Hip Dysfunction and Osteoarthritis Outcome Score(Baseline, 6,12 an 24 months follow-ups - only in some study sites)
- ASES Arthritis Self-Efficacy Scale(Baseline, 6,12 an 24 months follow-ups)
- Tampa scale of Kinesiophobia(Baseline, 6,12 an 24 months follow-ups)
- Hip Sports Activity Scale (HSAS)(Baseline, 6,12 an 24 months follow-ups)
- Work place Activity Limitation Survey (WALS)(Baseline, 6,12 an 24 months follow-ups)
- Patient Specific Functional Scale(Baseline, 6,12 an 24 months follow-up)
- Measures of hip physical impairment:(Baseline, 6,12 an 24 months follow-ups)
- Hip muscle strength(Baseline, 6,12 an 24 months follow-ups)
- Single leg squat performance(Baseline, 6,12 an 24 months follow-ups)
- Total Hip Replacement.(1, 2, 5 and 10 years follow-up)
研究者
May Arna Risberg
Professor
Oslo University Hospital