Hip DysplasiaNCT04591067
Physical Capacity Among Patients Treated With Periacetabular Osteotomy for Hip Dysplasia: a Cross-sectional Study
An observational study of Hip Dysplasia and Joint Diseases, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hip Dysplasia, Joint Diseases, Musculoskeletal Diseases
- What is being tested?
- Testing of physical capacity
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopedic Surgery, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark
Copenhagen, Hvidovre, 2650
About this 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.
Read the 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 Copenhagen University Hospital, Hvidovre.
- Conditions
- Hip Dysplasia, Joint Diseases, Musculoskeletal Diseases
- Being tested
- Testing of physical capacity
- Keywords
- Hip Dysplasia, Hip and muscle-tendon related groin pain, Musculoskeletal Diseases
- Medical subject headings
- Hip Dislocation, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of physical capacityOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Hip Dysplasia group | Subjects who have undergone a periacetabular osteotomy (PAO) for hip dysplasia within the last 1-5 years. Receives: Other: Testing of physical capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait function
Peak hip extension angle and peak hip flexor moment
Measured: Baseline
Secondary outcomes (5)
Gait function following fatigue
Peak hip extension angle and peak hip flexor moment following a 6-Minute walk test
Measured: Baseline
Muscle activity
Muscle activity of hip specific muscles during level walking and walking with inclination
Measured: Baseline
Maximal voluntary isometric hip muscle force
Adduction, abduction, flexion and extension
Measured: Baseline
Hip and muscle-tendon-related groin pain
FADIR and FABER, modified standardized clinical entity approach
Measured: Baseline
Hip specific patient reported outcome measures (PROMs)
Present level of physical activity and sports \& activity level prior to and after treatment with PAO
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Oppendieck Andersen, Copenhagen University Hospital, Hvidovre
- Investigators
- Per Hölmich, Professor, dr.med., Study director, Sports Orthopedic Research Center - Copenhagen (SORC-C), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591067
- Sponsor's protocol ID
- 20006975
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andersen SO, Ishoi L, Karabanov AN, Bencke J, Holmich P. Physical function in patients treated for hip dysplasia with periacetabular osteotomy and in some cases with supplementary hip arthroscopy: A cross-sectional study. Clin Biomech (Bristol). 2025 Dec;130:106677. doi: 10.1016/j.clinbiomech.2025.106677. Epub 2025 Oct 9.
PubMed 41138707
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Capacity Among Patients Treated With Periacetabular Osteotomy for Hip Dysplasia: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04591067
- Acronym / sponsor ID
- 20006975
- Conditions
- Hip Dysplasia, Joint Diseases, Musculoskeletal Diseases
- Keywords
- Hip Dysplasia, Hip and muscle-tendon related groin pain, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Copenhagen University Hospital, Hvidovre.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Dysplasia group | – | Other: Testing of physical capacitySubjects who have undergone a periacetabular osteotomy (PAO) for hip dysplasia within the last 1-5 years. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of physical capacityThis 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 groin pain 7. Hip and groin related patient-reported outcome measures (PROMs) | Other | Hip Dysplasia group |
Primary outcome
Gait function
Time frame: Baseline
Peak hip extension angle and peak hip flexor moment
5 secondary outcomes
Gait function following fatigue
Time frame: Baseline
Muscle activity
Time frame: Baseline
Maximal voluntary isometric hip muscle force
Time frame: Baseline
Hip and muscle-tendon-related groin pain
Time frame: Baseline
Hip specific patient reported outcome measures (PROMs)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 41138707Andersen SO, Ishoi L, Karabanov AN, Bencke J, Holmich P. Physical function in patients treated for hip dysplasia with periacetabular osteotomy and in some cases with supplementary hip arthroscopy: A cross-sectional study. Clin Biomech (Bristol). 2025 Dec;130:106677. doi: 10.1016/j.clinbiomech.2025.106677. Epub 2025 Oct 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hölmich, Professor, dr.med. study director
Sports Orthopedic Research Center - Copenhagen (SORC-C), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Dysplasia and Joint Diseases, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait function (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.