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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| VIA University College | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | PAO+usual+PRT |
|
| Group 2 | Active Comparator | PRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAO | Procedure | PAO will be performed as the trans-sartorial approach or the anterior pelvic approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain related to hip function, between baseline and 12 months 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). | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported hip function | The subscales; Symptoms, Physical function in daily living, Physical function in Sport and Recreation, Participation in Physical Activities and hip and/or groin-related Quality of Life of the patient reported questionnaire Copenhagen Hip and Groin Outcome Score (HAGOS), where the total score ranges from 0 (worst) to 100 (best). | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | Tri-axial accelerometer | Measured at baseline and 12 month follow-up |
| Change in patient-reported health | Change in patient-reported health will be measured with the EuroQol Group 5-dimension patient-reported questionnaire (EQ-5D-5L), where each dimension has five response levels; ranging from no problems to extreme problems (level 1 to level 5). The scores will be combined, using one level from each dimension, ranging from 11111 (best health) to 55555 (worst health). The instrument also includes a visual analogue scale (VAS) where self-perceived health is scored on a 0 to 100 mm scale representing "the worst health you can imagine" and "the best health you can imagine". |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa U Tønning, MSc | Department of Orthopedic Surgery, Aarhus University Hospital, Denmark | Principal Investigator |
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lisa Urup Tønning | Aarhus N | Central Jutland | 8200 | Denmark | ||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31874882 | Derived | 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. |
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Aarhus University Hospital is responsible for handling all personal data provided by both sites in accordance to the Clinical Trial Agreement and the EU General Data Protection Regulation (GDPR).
End of study and 5 years ahead
Oslo University Hospital agree that information directly related to the protocol and trial, including data, material, Intellectual Property and results generated from the trial shall be the property of Aarhus University Hospital, and shall be treated in strict confidence, and shall not be disclosed to any third party, or use for its benefit or the benefit of any third party, without the prior written consent of Aarhus University Hospital, except for data that is (i) publicly known or available from other sources who are not under a confidentially obligation to the other party; (li) has been made available by the other party without confidentiality obligation; or (iii) is independently developed or otherwise already known by or available to the other party without a confidentiality obligation; or (iv) is already required disclosed by law.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Primary analysis | Jan 17, 2022 | Jul 26, 2022 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Secondary analysis - Activity | May 26, 2026 | May 26, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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Randomized controlled trial
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Blinding
| Usual care after PAO | Other | 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 | Other | 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. |
|
| Change in hip function | Single leg hop for distance is a test that measure functional performance requiring both strength, power and balance. The distance from start to landing is measured in cm. and height adjusted by dividing the distance of the hop with the height of the patient. | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Change in balance function | The Y balance test require strength, flexibility, neuromuscular control, stability, range of movement, balance and proprioception. These elements are tested and the maximal reach distance is recorded for each direction (anterior, posteromedial and posteroladeral). The composite reach is calculated and normalized to limb length for analysis of the overall performance on the test. | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Number of patients with adverse events and serious adverse events after PAO | Adverse events:
Serious adverse events:
| Reported within 12 months after surgery |
| Change in usage of painkillers | Usage of painkillers (yes/no), including type of painkillers (Paracetamol, NSAID, Morfin/opiods and/other type of medicine) | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Change in self-reported pain | Pain reported by the Visual Analogue Scale (VAS). A scale where pain is marked from 0-100, and 0 is no pain and 100 is worst imaginable pain. | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Change in hip awareness | Hip awareness is measured with the Forgotten Joint Score questionnaire (FJS), where each patient completes the 12 questions regarding awareness of their affected hip. Each question is answered with one of the following options; never, almost never, seldom, sometimes and mostly, corresponding to a score of 1-5. The sum of the scores will be converted into a score between 0-100. A high score will indicate lack of awareness and a low score will indicate great awareness of the affected hip. | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Change in muscle strength | Muscle strength in hip-abduction, hip-flexion and hip-extension is measured isometrically, with a dynamometer. | Measured at baseline, 4 month follow-up and 12 month follow-up |
| Measured at baseline, 4 month follow-up and 12 month follow-up |
| Tone Bere, PT, PhD | Department of Orthopedics, Oslo University Hospital Ullevaal, Norway | Study Chair |
| May A Risberg, PhD | Department of Orthopedics, Oslo University Hospital Ullevaal, Norway | Study Director |
| Odense |
| Fyn |
| 5000 |
| Denmark |
| Oslo University Hospital | Oslo | 0450 | Norway |
| D025981 |
| Hip Injuries |