Soft Tissue Pathology in Hip Dysplasia Before and After Periacetabular Osteotomy

NCT02311166 | Completed DMC

• 1 other identifier: 20140401PAO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: The lack of congruence between the acetabulum and femoral head in hip dysplasia compromise the passive stability of the hip joint resulting in increased stress on the acetabular labrum, joint capsule and the muscles acting close to the hip joint. Soft tissue injury is present in hip dysplasia, and pathology of the iliopsoas muscle has been found in 18-50%. To our knowledge, no studies have systematically examined the prevalence of soft tissue pathology in hip dysplasia. The overall aim of this research project is to examine soft tissue pathology in 100 patients with hip dysplasia prior to and one year after Periacetabular osteotomy (PAO). Methods: Soft tissue pathology will be examined in a prospective cohort study on 100 patients with hip dysplasia prior to and one year after surgery. Pathology will be examined using ultrasonography and the Clinical Entities Approach that focus on pathology of the iliopsoas, adductors, rectus abdominis, gluteus medius and hamstrings. Furthermore, hip muscle strength is tested with a dynamometer, hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) and physical activity is measured with triaxial accelerometers during a period of 7 days. Perspective: Is it possible to demonstrate pathology of the hip muscles and tendons applying clinical tests, muscle strength tests, and ultrasonography, as it has been found in sports-active people with groin pain, it will make sense to plan and test a specific training program focusing on the pathological soft tissue pathology.

Conditions

Hip Dysplasia

Keywords

Hip dysplasia; Soft tissue; Hip; Self-report; Physical activity

Outcome Measures

Primary Outcomes (4)

• Soft tissue pathology in the hip region (xamined with the Clinical Entities Approach)

  Soft tissue pathology will be examined with the Clinical Entities Approach examining pathology of the iliopsoas, adductors, rectus abdominis, gluteus medius and hamstrings using a standardized and reliable examination protocol

  Prior to surgery and one year after surgery

• Soft tissue pathology of the hip region using a standardized ultrasonography protocol

  Soft tissue pathology of the iliopsoas, adductors, rectus abdominis, gluteus medius and hamstrings is examined using a standardized ultrasonography protocol.

  Prior to surgery and one year after surgery

• Hip related self-reports of health (Copenhagen Hip and Groin Outcome Score (HAGOS)

  Hip related health measured with the reliable Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with groin pain.

  Prior to surgery and one year after surgery

• Physical activity during a period of 7 days (measured with triaxial accelerometers)

  Physical activity is measured with triaxial accelerometers during a period of 7 days on the following categories: rest, standing, walking, sit to stand (STS), cycling and running.

  Prior to surgery and one year after surgery

Secondary Outcomes (6)

• Isometric hip muscle strength using a dynamometer

  Prior to surgery and one year after surgery

• Subjective visual analogue scale (VAS)

  Prior to surgery and one year after surgery

• Pain location registered on a pain-drawing

  Prior to surgery and one year after surgery

• Presence of internal snapping hip (examined with a standardized examination test)

  Prior to surgery and one year after surgery

• Presence of lumbar and thoracic back pathology

  Prior to surgery and one year after surgery

Other Outcomes (9)

• Wiberg's center-edge (CE) angle

  Prior to surgery and one year after surgery

• Tönnis' acetabular index (AI) angle

  Prior to surgery and one year after surgery

• Osteoarthritis grade

  Prior to surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of hip dysplasia receiving treatment at Aarhus University Hospital, Denmark.

You may qualify if:

• \. Diagnosis of hip dysplasia with a Wiberg´s Center-Edge (CE) angle \<25 degrees, and planned PAO surgery at Aarhus University Hospital

You may not qualify if:

• Osteoarthritis grade ≥2 using Tönnis' classification
• Other hip conditions as Calvé Perthes and epiphysiolysis
• Surgery due to discus disease and spondylodesis and joint preserving and alloplastic surgery at the hip, knee or angle region
• Neurological and/or rheumatological conditions affecting the function of the hip joint
• Tenotomy of the iliopsoas tendon
• BMI \> 40
• Cross-over sign (retroversion of the acetabulum)

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator

Study Sites (2)

Department of Orthopaedics, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital

Aarhus, Dk-8000, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Kjeld Soballe, Prof. Dr.med

  Department of Orthopaedic surgery, Aarhus University Hospital

  STUDY CHAIR

• Per Hölmich, Dr.med

  Arthroscopic Center Amager, Amager University Hospital

  STUDY CHAIR

• Kristian Thorborg, MSc, PhD

  Arthroscopic Center Amager, Amager University Hospital

  STUDY CHAIR

• Lars Bolvig, MD

  Department of Orthopaedic surgery, Aarhus University Hospital

  STUDY CHAIR

• Stig S Jakobsen, MD

  Department of Orthopaedic surgery, Aarhus University Hospital

  STUDY CHAIR

• Inger Mechlenburg, MSc, PhD

  Department of Orthopaedic surgery, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: December 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: April 8, 2021

Record last verified: 2014-03

Locations

DK (2)