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Soft Tissue Pathology in Hip Dysplasia Before and After Periacetabular Osteotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311166
Recruitment Status : Unknown
Verified March 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : March 1, 2016
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease
Hip Dysplasia

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Soft Tissue Pathology in 100 Patients With Hip Dysplasia Before and After Periacetabular Osteotomy
Study Start Date : April 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017



Primary Outcome Measures :
  1. Soft tissue pathology in the hip region (xamined with the Clinical Entities Approach) [ Time Frame: Prior to surgery and one year after surgery ]
    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

  2. Soft tissue pathology of the hip region using a standardized ultrasonography protocol [ Time Frame: Prior to surgery and one year after surgery ]
    Soft tissue pathology of the iliopsoas, adductors, rectus abdominis, gluteus medius and hamstrings is examined using a standardized ultrasonography protocol.

  3. Hip related self-reports of health (Copenhagen Hip and Groin Outcome Score (HAGOS) [ Time Frame: Prior to surgery and one year after surgery ]
    Hip related health measured with the reliable Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with groin pain.

  4. Physical activity during a period of 7 days (measured with triaxial accelerometers) [ Time Frame: Prior to surgery and one year after surgery ]
    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.


Secondary Outcome Measures :
  1. Isometric hip muscle strength using a dynamometer [ Time Frame: Prior to surgery and one year after surgery ]
    Isometric hip muscle strength of the hip flexors, hip abductors, hip adductors and hip extensors using a dynamometer

  2. Subjective visual analogue scale (VAS) [ Time Frame: Prior to surgery and one year after surgery ]
    Subjective visual analogue scale (VAS) at rest and during hip muscle strength tests.

  3. Pain location registered on a pain-drawing [ Time Frame: Prior to surgery and one year after surgery ]
    In an anatomical picture of a human body the patients records pain areas on the drawing.

  4. Presence of internal snapping hip (examined with a standardized examination test) [ Time Frame: Prior to surgery and one year after surgery ]
    Presence of internal snapping hip examined with a standardized examination test.

  5. Presence of lumbar and thoracic back pathology [ Time Frame: Prior to surgery and one year after surgery ]
    Presence of lumbar and thoracic back pathology is examined with the reliable Spine Springing Tests of the spinous process and processus transversi and of the sacrum.

  6. Conjoint tendon pathology [ Time Frame: Prior to surgery and one year after surgery ]
    Conjoint tendon pathology is examined with palpation of the pubic tubercle and ultrasonography of the pubic tubercle.


Other Outcome Measures:
  1. Wiberg's center-edge (CE) angle [ Time Frame: Prior to surgery and one year after surgery ]
    CE angel is measured on anteroposterior radiographs

  2. Tönnis' acetabular index (AI) angle [ Time Frame: Prior to surgery and one year after surgery ]
    Measured on anteroposterior radiographs

  3. Osteoarthritis grade [ Time Frame: Prior to surgery ]
    Measured on anteroposterior radiographs

  4. Duration of pain [ Time Frame: Prior to surgery ]
  5. Intake of analgesia [ Time Frame: Prior to surgery and one year after surgery ]
  6. Preferred physical activity and hours spend on this [ Time Frame: Prior to surgery and one year after surgery ]
  7. Body Mass Index [ Time Frame: Prior to surgery and one year after surgery ]
  8. Age [ Time Frame: Prior to surgery ]
  9. Hours spend on general physical activity [ Time Frame: Prior to surgery and one year after surgery ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of hip dysplasia receiving treatment at Aarhus University Hospital, Denmark.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311166


Locations
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Denmark
Department of Orthopaedics, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital
Aarhus, Denmark, Dk-8000
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Investigators
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Study Chair: 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 Director: Inger Mechlenburg, MSc, PhD Department of Orthopaedic surgery, Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02311166    
Other Study ID Numbers: 20140401PAO
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Aarhus:
Hip dysplasia
Soft tissue
Hip
Self-report
Physical activity
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Hyperplasia
Pathologic Processes
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities