Condition or disease | Intervention/treatment | Phase |
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Hip Dysplasia | Procedure: PAO Other: Usual care after PAO Other: PRT | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized controlled trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Blinding |
Primary Purpose: | Treatment |
Official Title: | The Effect of PAO Followed by Progressive Resistance Training Versus Progressive Resistance Training in Patients With Hip Dysplasia. A Randomized Controlled Trial |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | January 31, 2025 |
Estimated Study Completion Date : | January 31, 2026 |
Arm | Intervention/treatment |
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Experimental: Group 1
PAO+usual+PRT
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Procedure: PAO
PAO will be performed as the trans-sartorial approach or the anterior pelvic approach.
Other: 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.
Other: 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.
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Active Comparator: Group 2
PRT
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Other: 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.
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Adverse events:
Serious adverse events:
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa CU Reimer, MSc | +45 26474080 | lisareimer@clin.au.dk | |
Contact: Inger Mechlenburg, DMSc, PhD | +45 21679062 | inger.mechlenburg@clin.au.dk |
Denmark | |
Aarhus University Hospital | Recruiting |
Aarhus, Midtjylland, Denmark, 8240 | |
Contact: Lisa Cecilie U Reimer, MSc 26474080 lisaurup@gmail.com | |
Contact: Inger Mechleburg, DMSc +45 2167 9062 Inger.mechlenburg@clin.au.dk | |
Norway | |
Oslo University Hospital | Recruiting |
Oslo, Norway, 0450 | |
Contact: Tone Bere, PhD |
Principal Investigator: | Lisa CU Reimer, MSc | Department of Orthopedic Surgery, Aarhus University Hospital, Denmark | |
Study Director: | Inger Mechlenburg, DMSc, PhD | Department of Clinical Medicine, Aarhus University, Denmark | |
Study Director: | Ulrik Dalgas, MSc, PhD | Department of Public Health - Sport, Aarhus University, Denmark | |
Study Director: | Stig S Jakobsen, PhD | Department of Orthopedic Surgery, Aarhus University Hospital, Denmark | |
Study Director: | Kjeld Søballe, DMSc | Department of Orthopedic Surgery, Aarhus University Hospital, Denmark | |
Study Director: | Julie S Jacobsen, MSc | Department of Physiotherapy & Research Centre in Health and Welfare Technology, VIA University College, Denmark | |
Study Director: | Jan E Madsen, MD, PhD | Department of Orthopedic Surgery, Oslo University Hospital, Norway | |
Study Director: | Lars Nordsletten, PhD | Division of Orthopaedic Surgery, Oslo University Hospital, Oslo; Faculty of Medicine, University of Oslo, Norway | |
Study Chair: | Tone Bere, PT, PhD | Department of Orthopedics, Oslo University Hospital Ullevaal, Norway | |
Study Director: | May A Risberg, PhD | Department of Orthopedics, Oslo University Hospital Ullevaal, Norway |
Tracking Information | |||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | April 29, 2019 | ||||||||||||||||||||||||||||||
First Posted Date ICMJE | May 7, 2019 | ||||||||||||||||||||||||||||||
Last Update Posted Date | March 11, 2021 | ||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||||||||||||||||||||||||
Estimated Primary Completion Date | January 31, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Change in pain related to hip function, between baseline and 12 months follow-up [ Time Frame: 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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||
Brief Title ICMJE | Is Periacetabular Osteotomy Superior to Progressive Resistance Training? | ||||||||||||||||||||||||||||||
Official Title ICMJE | The Effect of PAO Followed by Progressive Resistance Training Versus Progressive Resistance Training in Patients With Hip Dysplasia. A Randomized Controlled Trial | ||||||||||||||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized controlled trial Masking: Single (Outcomes Assessor)Masking Description: Blinding Primary Purpose: Treatment
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Condition ICMJE | Hip Dysplasia | ||||||||||||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||||||||
Estimated Enrollment ICMJE |
96 | ||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||||||||||||||
Estimated Study Completion Date ICMJE | January 31, 2026 | ||||||||||||||||||||||||||||||
Estimated Primary Completion Date | January 31, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Denmark, Norway | ||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT03941171 | ||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | PreserveHIP | ||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Aarhus | ||||||||||||||||||||||||||||||
Study Sponsor ICMJE | University of Aarhus | ||||||||||||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Aarhus | ||||||||||||||||||||||||||||||
Verification Date | November 2020 | ||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |