The Effect of PAO Followed by Progressive Resistance Training Versus Progressive Resistance Training in Patients With Hip Dysplasia. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Change in pain related to hip function, between baseline and 12 months follow-up
研究概览
简要总结
The primary aim of this study is to examine if Periacetabular Osteotomy (PAO) followed by 4 months of usual care followed by 8 months of progressive resistance training (PRT) is superior to 12 months of a PRT intervention in patients with hip dysplasia eligible for PAO in terms of self-reported pain on the HAGOS questionnaire. Secondary aims are to investigate changes in patient-reported symptoms, physical function in daily living, physical function in sport and recreation, hip and/or groin-related quality of life, generic health status, functional performance, muscle strength, physical activity and adverse events between PAO followed by usual care+PRT compared to PRT only. We hypothesise that in patients with hip dysplasia, PAO followed by usual care+PRT, results in significantly less pain at 12 months follow-up, compared to PRT only.
详细描述
Group 1 (PAO+usual+PRT):
PAO will be performed as the trans-sartorial approach or the anterior pelvic approach. Patients commence post-operative rehabilitation as usual and follow the rehabilitation program guided by a physiotherapist specialized in hip problems until 4 months after the operation. 4 months postoperative the patients complete usual care and continue with the same PRT intervention program as the PRT group, with 4 months of supervised sessions (see description below).
Group 2 (PRT):
The PRT group receives 4 months of supervised PRT 2 times per week. A physiotherapist or students will supervise all training sessions the first 4 weeks. The following 4 weeks, 6 out of 8 training sessions are supervised and from week 9-16, half of the training sessions (8 out of 16) are supervised. After these 4 months (16 weeks), patients receive a free membership to a fitness center near their home address and are encouraged to train on their own 2 times per week until 12 months follow-up with one supervised session per month. The PRT program involves 10-min of warm up followed by 50-min of bilateral resistance exercises including sets of loaded squats, hip extension, hip flexion, and hip abduction. The absolute training load will be individually adjusted on a set-by-set basis, using the plus two principle (if the patient is able to perform two or more repetitions than required, the load is increased). Hip related pain levels up to 5 on the VAS is considered acceptable during exercise.
The study is a multicentre randomised controlled and assessor blinded trial. Primary endpoint will be 12 months after initiation of surgical/non-surgical treatment. Secondary endpoints will be measured at 4 months after the start of the treatment (surgical/non-surgical). In addition, 5-year and 10-year follow-up with questionnaires is planned.
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)
盲法说明
Blinding
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-45 years and diagnosed with hip dysplasia referred from primary care to the Department of Orthopaedic Surgery at one of the two participating hospitals.
- •Considered eligible for PAO by a surgeon.
- •Radiographic verified hip dysplasia (CE-angle <25 degrees and AI-angle >10 degrees) and clinical symptoms.
- •Range of motion: internal rotation >15 degrees, external rotation >15 degrees, hip flexion >110 degrees.
- •Able to commute to training sessions.
排除标准
- •OA degree ≥1 on classification of Tönnis'.
- •CE-angle <10 degrees.
- •Previous pelvic surgery for hip dysplasia (affected side).
- •Calvé Legg Perthes or epifysiolysis.
- •Simultaneous bilateral PAO.
- •Previous surgery for herniated disc, spondylodesis, arthroplasty of hip, knee or ankle.
- •Previous surgery of the hip (tenotomy of iliopsoas tendon, z-plastic of the iliotibial tract or hip arthroscopy) in index leg.
- •Neurological or rheumatoid diseases that affect the hip function.
- •Inadequacy in written and spoken Danish or Norwegian.
- •Body Mass Index (BMI) >25 in Aarhus and BMI >30 in Oslo and Odense
研究组 & 干预措施
Group 1
PAO+usual+PRT
干预措施: PAO (Procedure)
Group 1
PAO+usual+PRT
干预措施: Usual care after PAO (Other)
Group 1
PAO+usual+PRT
干预措施: PRT (Other)
Group 2
PRT
干预措施: PRT (Other)
结局指标
主要结局
Change in pain related to hip function, between baseline and 12 months follow-up
时间窗: Measured at baseline, 4 month follow-up and 12 month follow-up
The pain subscale of the patient reported questionnaire Copenhagen Hip and Groin Outcome Score (HAGOS), were the total score ranges from 0 (worst) to 100 (best).
次要结局
- Number of patients with adverse events and serious adverse events after PAO(Reported within 12 months after surgery)
- Change in self-reported pain(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in self-reported hip function(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in hip function(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in balance function(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in hip awareness(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in usage of painkillers(Measured at baseline, 4 month follow-up and 12 month follow-up)
- Change in muscle strength(Measured at baseline, 4 month follow-up and 12 month follow-up)