- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04590924
HAFAI Cohort 5 Year Follow up of Patients With Femoroacetabular Impingement Undergoing Hip Arthroscopy
July 5, 2021 updated by: Jeppe Lange, Horsens Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Danmark
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Horsens, Danmark, Denmark, DK-8700
- Signe Kierkegaard
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients included in the HAFAI cohort 5 years ago.
Description
Inclusion Criteria:
- Included in the HAFAI cohort
Exclusion Criteria:
- Non
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Score at 5 years and change from before surgery to 5 years after surgery
|
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)
|
Score at 5 years and change from before surgery to 5 years after surgery
|
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
|
Score at 5 years and change from before surgery to 5 years after surgery
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of daily living 5 years after surgery
Time Frame: Score at 5 years and change from before surgery to 5 years after surgery
|
Activities of daily living 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
|
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
|
Hip related quality of life 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)
|
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 measured with the Copenhagen hip and groin scale (0-100 score)
|
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
|
Participation in sport 5 years after surgery measured with Hip Sports activity scale
|
Score at 5 years and change from before surgery to 5 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Signe Kierkegaard, PhD, Horsens Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
September 4, 2019
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-1-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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