Clinical trial NCT03941171: Is Periacetabular Osteotomy Superior to Progressive Resistance Training?
Official title: The Effect of PAO Followed by Progressive Resistance Training Versus Progressive Resistance Training in Patients With Hip Dysplasia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Dysplasia
Keywords: Periacetabular Osteotomy
Progressive resistance training
PAO
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: VIA University College
First posted: 2019-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Considered eligible for PAO by a surgeon.
3. Radiographic verified hip dysplasia (CE-angle \<25 degrees and AI-angle \>10 degrees) and clinical symptoms.
4. Range of motion: internal rotation \>15 degrees, external rotation \>15 degrees, hip flexion \>110 degrees.
5. Able to commute to training sessions.

Exclusion Criteria:

1. OA degree ≥1 on classification of Tönnis'.
2. CE-angle \<10 degrees.
3. Previous pelvic surgery for hip dysplasia (affected side).
4. Calvé Legg Perthes or epifysiolysis.
5. Simultaneous bilateral PAO.
6. Previous surgery for herniated disc, spondylodesis, arthroplasty of hip, knee or ankle.
7. Previous surgery of the hip (tenotomy of iliopsoas tendon, z-plastic of the iliotibial tract or hip arthroscopy) in index leg.
8. Neurological or rheumatoid diseases that affect the hip function.
9. Inadequacy in written and spoken Danish or Norwegian.
10. Body Mass Index (BMI) \>25 in Aarhus and BMI \>30 in Oslo and Odense

Primary outcomes:
measure: Change in pain related to hip function, between baseline and 12 months follow-up
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
Secondary outcomes:
measure: Change in self-reported hip function
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Change in hip function
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Change in balance function
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Number of patients with adverse events and serious adverse events after PAO
timeFrame: Reported within 12 months after surgery
measure: Change in usage of painkillers
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Change in self-reported pain
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Change in hip awareness
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
measure: Change in muscle strength
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
Other outcomes:
measure: Change in physical activity
timeFrame: Measured at baseline and 12 month follow-up
measure: Change in patient-reported health
timeFrame: Measured at baseline, 4 month follow-up and 12 month follow-up
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
city: Aarhus N
country: Denmark
facility: Lisa Urup Tønning
state: Midtjylland
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
name: Lisa U Tønning, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Medicine, Aarhus University, Denmark
name: Inger Mechlenburg, DMSc, PhD
role: STUDY_DIRECTOR
affiliation: Department of Public Health - Sport, Aarhus University, Denmark
name: Ulrik Dalgas, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
name: Stig S Jakobsen, PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
name: Kjeld Søballe, DMSc
role: STUDY_DIRECTOR
affiliation: Department of Physiotherapy & Research Centre in Health and Welfare Technology, VIA University College, Denmark
name: Julie S Jacobsen, MSc
role: STUDY_DIRECTOR
affiliation: Department of Orthopedic Surgery, Oslo University Hospital, Norway
name: Jan E Madsen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Division of Orthopaedic Surgery, Oslo University Hospital, Oslo; Faculty of Medicine, University of Oslo, Norway
name: Lars Nordsletten, PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthopedics, Oslo University Hospital Ullevaal, Norway
name: Tone Bere, PT, PhD
role: STUDY_CHAIR
affiliation: Department of Orthopedics, Oslo University Hospital Ullevaal, Norway
name: May A Risberg, PhD
role: STUDY_DIRECTOR
References:
citation: Reimer LCU, Jakobsen SS, Mortensen L, Dalgas U, Jacobsen JS, Soballe K, Bere T, Madsen JE, Nordsletten L, Risberg MA, Mechlenburg I. Efficacy of periacetabular osteotomy followed by progressive resistance training compared to progressive resistance training as non-surgical treatment in patients with hip dysplasia (PreserveHip) - a protocol for a randomised controlled trial. BMJ Open. 2019 Dec 23;9(12):e032782. doi: 10.1136/bmjopen-2019-032782.