Is Periacetabular Osteotomy Superior to Progressive Resistance Training?
NCT ID: NCT03941171
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2019-07-01
2025-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
PAO+usual+PRT
PAO
PAO will be performed as the trans-sartorial approach or the anterior pelvic approach.
Usual care after PAO
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.
PRT
4 months of partly supervised progressive resistance training 2 times per week. 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 squats, hip extension, hip flexion, and hip abduction.
Group 2
PRT
PRT
4 months of partly supervised progressive resistance training 2 times per week. 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 squats, hip extension, hip flexion, and hip abduction.
Interventions
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PAO
PAO will be performed as the trans-sartorial approach or the anterior pelvic approach.
Usual care after PAO
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.
PRT
4 months of partly supervised progressive resistance training 2 times per week. 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 squats, hip extension, hip flexion, and hip abduction.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
40 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
VIA University College
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lisa U Tønning, MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
Inger Mechlenburg, DMSc, PhD
Role: STUDY_DIRECTOR
Department of Clinical Medicine, Aarhus University, Denmark
Ulrik Dalgas, MSc, PhD
Role: STUDY_DIRECTOR
Department of Public Health - Sport, Aarhus University, Denmark
Stig S Jakobsen, PhD
Role: STUDY_DIRECTOR
Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
Kjeld Søballe, DMSc
Role: STUDY_DIRECTOR
Department of Orthopedic Surgery, Aarhus University Hospital, Denmark
Julie S Jacobsen, MSc
Role: STUDY_DIRECTOR
Department of Physiotherapy & Research Centre in Health and Welfare Technology, VIA University College, Denmark
Jan E Madsen, MD, PhD
Role: STUDY_DIRECTOR
Department of Orthopedic Surgery, Oslo University Hospital, Norway
Lars Nordsletten, PhD
Role: STUDY_DIRECTOR
Division of Orthopaedic Surgery, Oslo University Hospital, Oslo; Faculty of Medicine, University of Oslo, Norway
Tone Bere, PT, PhD
Role: STUDY_CHAIR
Department of Orthopedics, Oslo University Hospital Ullevaal, Norway
May A Risberg, PhD
Role: STUDY_DIRECTOR
Department of Orthopedics, Oslo University Hospital Ullevaal, Norway
Locations
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Lisa Urup Tønning
Aarhus N, Central Jutland, Denmark
Odense University Hospital
Odense, Fyn, Denmark
Oslo University Hospital
Oslo, , Norway
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PreserveHIP
Identifier Type: -
Identifier Source: org_study_id