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Physical Capacity Among Patients Treated With Periacetabular Osteotomy for Hip Dysplasia: a Cross-sectional Study

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ClinicalTrials.gov Identifier: NCT04591067
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sally Oppendieck Andersen, Copenhagen University Hospital, Hvidovre

Brief Summary:
This cross-sectional study investigates the physical capacity of patients, who have undergone a periacetabular osteotomy for hip dysplasia within the last 1-5 years.

Condition or disease Intervention/treatment
Hip Dysplasia Joint Diseases Musculoskeletal Diseases Other: Testing of physical capacity

Detailed Description:

Hip dysplasia is a common disease both worldwide and among the Danish population. The disease is characterized by a shallow and oblique acetabulum, resulting in insufficient coverage of the femoral head. The abnormalities of the dysplastic hip joint lead to altered biomechanical adaptations, highly affecting the physical capacity of patients. Studies have shown that patients with hip dysplasia experience reduced muscle strength and gait abnormalities, when compared to healthy controls.

Each year, approximately 200 Danes with hip dysplasia are treated with periacetabular osteotomy (PAO). As the preferable joint-preserving surgical treatment for younger patients with symptomatic hip dysplasia, the PAO reduces prevalence of muscle-tendon-related pain and improves hip and groin related patient-reported outcome measures (PROMs). By extension, studies report a hip survival rate of approximately 75% 12 years following PAO.

However, little is known about objective measures of physical capacity following PAO. Despite reducing muscle-tendon-related pain and improving PROMs, gait adaptations still remain and studies report no improvements in muscle strength, nor in the physical activity profile, 1 year following treatment with PAO. Thus, the field calls for research aiming to identify parameters of impaired physical capacity in patients treated with PAO. Thorough knowledge of physical capacity in these patients may contribute to the establishment of a science-based rehabilitation strategy, potentially improving physical activity, function, work capacity and quality of life.

The primary aim of this study is to analyse and identify parameters of impaired physical capacity in patients with hip dysplasia 1-5 years following treatment with PAO. Gait function, defined as peak hip extension angle and peak hip flexor moment, is chosen as the primary outcome, due to previously shown correlations between the extent of gait impairments and the Copenhagen Hip and Groin Outcome Score (HAGOS).

As recommended by the International Hip-related Pain Research Network (IHiPRN), measurements of physical capacity in patients with hip-related pain should include: clinical measures, laboratory-based measures, measures of physical activity and return to physical activity. Secondary outcomes of this study are: muscle activity during level walking and walking with inclination, endurance and pain during walking, range of motion (ROM), muscle strength, hip and muscle-tendon-related pain, radiographic measures and PROMs (present level of physical activity and sports & activity level prior to and after treatment with PAO).

We hypothesise that patients with the lowest scores of HAGOS subscales pain and sport/recreation will have the lowest physical capacity, measured as: gait impairments, reduced muscle strength and prevalence of muscle-tendon-related pain.

This is a cross-sectional study.

Thirty subjects from across the country, aged 18-40 years, who have undergone a PAO for hip dysplasia within the last 1-5 years, will be included in the study.

All testing will be performed at Hvidovre Hospital.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physical Capacity Among Patients Treated With Periacetabular Osteotomy for Hip Dysplasia: a Cross-sectional Study
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Hip Dysplasia group
Subjects who have undergone a periacetabular osteotomy (PAO) for hip dysplasia within the last 1-5 years.
Other: Testing of physical capacity

This cross-sectional study will involve evaluation of physical capacity by assessment of:

  1. Gait function
  2. Muscle activity during walking
  3. Endurance during walking
  4. Hip muscle strength
  5. Hip range of motion
  6. Hip and muscle-tendon-related pain
  7. Hip and groin related patient-reported outcome measures (PROMs)




Primary Outcome Measures :
  1. Gait function [ Time Frame: Baseline ]
    Peak hip extension angle and peak hip flexor moment


Secondary Outcome Measures :
  1. Gait function following fatigue [ Time Frame: Baseline ]
    Peak hip extension angle and peak hip flexor moment following a 6-Minute walking test

  2. Muscle activity [ Time Frame: Baseline ]
    Muscle activity of hip specific muscles during level walking and walking with inclination

  3. Maximal voluntary isometric hip muscle force [ Time Frame: Baseline ]
    Adduction, abduction, flexion and extension

  4. Hip and muscle-tendon-related pain [ Time Frame: Baseline ]
    FADIR and FABER, modified standardized clinical entity approach

  5. Hip specific patient reported outcome measures (PROMs) [ Time Frame: Baseline ]
    Present level of physical activity and sports & activity level prior to and after treatment with PAO



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who have undergone a periacetabular osteotomy (PAO) for hip dysplasia within the last 1-5 years.

Subjects will be recruited through social media from two specific closed-member facebook groups for patients with hip dysplasia. Permission for recruiting through social media was granted by The Danish Data Protection Agency along with permission for the handling of personal data (P-2020-261).

Criteria

Inclusion Criteria:

  • Age 18 to 40 years
  • BMI < 30
  • Primary diagnosis of ipsilateral or bilateral hip dysplasia
  • Treated with PAO for hip dysplasia ipsilateral or bilaterally within 1-5 years

Exclusion Criteria:

  • A need for walking aids to be able to walk freely
  • Treated with PAO primarily for retroverted acetabulum (reversed PAO)
  • Total Hip Arthroplasty (THA)
  • Medical treatment for neurological diseases

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): NCT04591067


Contacts
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Contact: Sally Oppendieck Andersen, stud. cand. scient. hum. fys. +45 28 35 58 09 sally.o.andersen@gmail.com

Locations
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Denmark
Department of Orthopaedic Surgery, Hvidovre Hospital Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Sally Oppendieck Andersen, stud. cand. scient. hum. fys.    +45 28 35 58 09    sally.o.andersen@gmail.com   
Sub-Investigator: Per Hölmich, Professor, dr.med.         
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Study Director: Per Hölmich, Professor, dr.med. Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
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Responsible Party: Sally Oppendieck Andersen, stud. cand. scient., hum. fys.. BSc Exercise Science, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT04591067    
Other Study ID Numbers: 20006975
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sally Oppendieck Andersen, Copenhagen University Hospital, Hvidovre:
Hip Dysplasia
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Hip Dislocation
Hip Dislocation, Congenital
Hyperplasia
Pathologic Processes
Joint Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities