Femoro Acetabular ImpingementNCT04590924
HAFAI Cohort 5 Year Follow up of Patients With Femoroacetabular Impingement Undergoing Hip Arthroscopy
An observational study of Femoro Acetabular Impingement, run by Horsens Hospital at 1 site in Denmark.
Trial summary
Patients included in the HAFAI cohort will be invited for 5 year follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- Hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the HAFAI cohort 5 years ago.
Who may be able to join
- Included in the HAFAI cohort
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain, Function and Hip Osteoarthritis 5 Years After Hip Arthroscopic Surgery in Patients With Femoroacetabular Impingement
Patients included in the HAFAI cohort will be invited for 5 year follow up.
Read the detailed description
Patients with femoroacetabular impingement will be investigated 5 years after surgery. We will used the Copenhagen Hip and Groin Score to evaluate pain, activities of daily living, sport, participation in sport and hip-related quality of life. Furthermore, degree of hip osteoarthritis will be evaluated using standing x-rays. Last, we will investigate number of re-operations and conversions to total hip replacement.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- Hip arthroscopy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroscopyProcedure or surgery
Patients that had hip arthroscopic surgery 5 years ago will be invited for 5 year follow up. The surgical procedures consisted of femoral osteoplasty, labral refixation and acetabular osteoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain 5 years after surgery
Pain 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Sports function 5 years after surgery
Sports function 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Development of osteoarthritis 5 years after surgery
Lateral hip joint space width measured at anterior posterior standing radiographs
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Re-operation
Re-operation/total hip replacement
Measured: From date of initial surgery until the date of first documented re-operation or total hip replacement, whichever came first, assessed up to 6 years after initial surgery
Secondary outcomes (4)
Activities of daily living 5 years after surgery
Activities of daily living 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Hip related quality of life 5 years after surgery
Hip related quality of life 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Participation in sport 5 years after surgery (HAGOS)
Participation in sport 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Measured: Score at 5 years and change from before surgery to 5 years after surgery
Participation in sport 5 years after surgery (HSAS)
Participation in sport 5 years after surgery measured with Hip Sports activity scale
Measured: Score at 5 years and change from before surgery to 5 years after surgery
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 Jan 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Femoro Acetabular ImpingementStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Lange, Horsens Hospital
- Investigators
- Signe Kierkegaard, PhD, Principal investigator, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590924
- Sponsor's protocol ID
- 1-10-72-1-19
- Status last verified
- Jul 2021
- First submitted
- 4 Sep 2019
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kierkegaard S, Mechlenburg I, Dalgas U, Lund B. Five-Year Follow-up After Hip Arthroscopic Surgery in the Horsens-Aarhus Femoroacetabular Impingement (HAFAI) Cohort. Orthop J Sports Med. 2022 Mar 8;10(3):23259671221075653. doi: 10.1177/23259671221075653. eCollection 2022 Mar.
PubMed 35284589
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Function and Hip Osteoarthritis 5 Years After Hip Arthroscopic Surgery in Patients With Femoroacetabular Impingement
- ClinicalTrials.gov ID
- NCT04590924
- Acronym / sponsor ID
- 1-10-72-1-19
- Conditions
- Femoro Acetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (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.
Patients included in the HAFAI cohort will be invited for 5 year follow up.
Detailed description
Patients with femoroacetabular impingement will be investigated 5 years after surgery. We will used the Copenhagen Hip and Groin Score to evaluate pain, activities of daily living, sport, participation in sport and hip-related quality of life. Furthermore, degree of hip osteoarthritis will be evaluated using standing x-rays. Last, we will investigate number of re-operations and conversions to total hip replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the HAFAI cohort 5 years ago.
Key inclusion criteria (1 listed)
- Included in the HAFAI cohort
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| Hip arthroscopyPatients that had hip arthroscopic surgery 5 years ago will be invited for 5 year follow up. The surgical procedures consisted of femoral osteoplasty, labral refixation and acetabular osteoplasty | Procedure or surgery | – |
Primary outcome
Pain 5 years after surgery
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Pain 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Sports function 5 years after surgery
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Sports function 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
Development of osteoarthritis 5 years after surgery
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Lateral hip joint space width measured at anterior posterior standing radiographs
Re-operation
Time frame: From date of initial surgery until the date of first documented re-operation or total hip replacement, whichever came first, assessed up to 6 years after initial surgery
Re-operation/total hip replacement
4 secondary outcomes
Activities of daily living 5 years after surgery
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Hip related quality of life 5 years after surgery
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Participation in sport 5 years after surgery (HAGOS)
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
Participation in sport 5 years after surgery (HSAS)
Time frame: Score at 5 years and change from before surgery to 5 years after surgery
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 7 Jul 2021.
- Derived from this study: PubMed 35284589Kierkegaard S, Mechlenburg I, Dalgas U, Lund B. Five-Year Follow-up After Hip Arthroscopic Surgery in the Horsens-Aarhus Femoroacetabular Impingement (HAFAI) Cohort. Orthop J Sports Med. 2022 Mar 8;10(3):23259671221075653. doi: 10.1177/23259671221075653. eCollection 2022 Mar.
- 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.
Signe Kierkegaard, PhD principal investigator
Horsens Hospital
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 Femoro Acetabular Impingement, run by Horsens Hospital 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 1 inclusion and 1 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 7 Jul 2021. 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?
Pain 5 years after surgery (time frame: Score at 5 years and change from before surgery to 5 years after surgery). The study lists 4 primary outcomes in all. 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 NCT04590924, 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 7 Jul 2021.