Is Periacetabular Osteotomy Superior to Progressive Resistance Training?

NCT03941171 | Completed DMC

• 1 other identifier: PreserveHIP
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hip Dysplasia

Keywords

Periacetabular Osteotomy; Progressive resistance training; PAO

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• Number of patients with adverse events and serious adverse events after PAO

  Reported within 12 months after surgery

• Change in usage of painkillers

  Measured at baseline, 4 month follow-up and 12 month follow-up

Other Outcomes (2)

• Change in physical activity

  Measured at baseline and 12 month follow-up

• Change in patient-reported health

  Measured at baseline, 4 month follow-up and 12 month follow-up

Study Arms (2)

Group 1

EXPERIMENTAL

PAO+usual+PRT

Procedure: PAO; Other: Usual care after PAO; Other: PRT

Group 2

ACTIVE COMPARATOR

PRT

Other: PRT

Interventions

PAO PROCEDURE

PAO will be performed as the trans-sartorial approach or the anterior pelvic approach.

Group 1

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.

Group 1

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• VIA University College: collaborator

Study Sites (3)

Lisa Urup Tønning

Aarhus N, Central Jutland, 8200, Denmark

Location

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (1)

• 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.

  PMID: 31874882 DERIVED

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• 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

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 7, 2019
• Study Start: July 1, 2019
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: End of study and 5 years ahead
• Access Criteria: 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.

Locations

DK (2); NO (1)