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Completed

NCT Number: NCT04591067

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopedic Surgery, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark

Copenhagen, Hvidovre, 2650, Denmark

About this study

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 Copenhagen University Hospital, Hvidovre.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Retroverted acetabulum (positive posterior wall sign and ischial spine sign) treated with reversed PAO
  • Total Hip Arthroplasty (THA)
  • Pain management with analgesics or other medication affecting muscle function and perception of pain
  • A need for walking aids to be able to walk freely

Treatment and study plan

Testing of physical capacity

Other

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

  • Gait function
  • Muscle activity during walking
  • Endurance during walking
  • Hip muscle strength
  • Hip range of motion
  • Hip and muscle-tendon-related groin pain
  • Hip and groin related patient-reported outcome measures (PROMs)

Primary outcomes

  1. Gait function

    Time frame: Baseline

    Peak hip extension angle and peak hip flexor moment

Secondary outcomes

  1. Gait function following fatigue

    Time frame: Baseline

    Peak hip extension angle and peak hip flexor moment following a 6-Minute walk 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 groin 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

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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