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

Sponsor
Copenhagen University Hospital, Hvidovre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04591067
Collaborator
(none)
30
1
27
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Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jun 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gait function [Baseline]

    Peak hip extension angle and peak hip flexor moment

Secondary Outcome Measures

  1. Gait function following fatigue [Baseline]

    Peak hip extension angle and peak hip flexor moment following a 6-Minute walking test

  2. Muscle activity [Baseline]

    Muscle activity of hip specific muscles during level walking and walking with inclination

  3. Maximal voluntary isometric hip muscle force [Baseline]

    Adduction, abduction, flexion and extension

  4. Hip and muscle-tendon-related pain [Baseline]

    FADIR and FABER, modified standardized clinical entity approach

  5. Hip specific patient reported outcome measures (PROMs) [Baseline]

    Present level of physical activity and sports & activity level prior to and after treatment with PAO

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Orthopedic Surgery, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark Copenhagen Hvidovre Denmark 2650

Sponsors and Collaborators

  • Copenhagen University Hospital, Hvidovre

Investigators

  • Study Director: Per Hölmich, Professor, dr.med., Sports Orthopedic Research Center - Copenhagen (SORC-C), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sally Oppendieck Andersen, BSc Exercise Science, MSc Human Physiology, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT04591067
Other Study ID Numbers:
  • 20006975
First Posted:
Oct 19, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sally Oppendieck Andersen, BSc Exercise Science, MSc Human Physiology, Copenhagen University Hospital, Hvidovre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022