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HAFAI Cohort 5 Year Follow up of Patients With Femoroacetabular Impingement Undergoing Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT04590924
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, Horsens Hospital

Brief Summary:
Patients included in the HAFAI cohort will be invited for 5 year follow up.

Condition or disease Intervention/treatment
Femoro Acetabular Impingement Procedure: Hip arthroscopy

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain, Function and Hip Osteoarthritis 5 Years After Hip Arthroscopic Surgery in Patients With Femoroacetabular Impingement
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Hip arthroscopy
    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


Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients included in the HAFAI cohort 5 years ago.
Criteria

Inclusion Criteria:

  • Included in the HAFAI cohort

Exclusion Criteria:

  • Non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590924


Contacts
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Contact: Signe Kierkegaard, PhD 0045 7842 7882 signekierkegaard@hotmail.com

Locations
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Denmark
Signe Kierkegaard Recruiting
Horsens, Danmark, Denmark, DK-8700
Contact: Signe Kierkegaard, PhD       signkier@rm.dk   
Contact: Bent Lund, MD       bentlund@rm.dk   
Sponsors and Collaborators
Horsens Hospital
Investigators
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Principal Investigator: Signe Kierkegaard, PhD Horsens Hospital
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Responsible Party: Jeppe Lange, Primary investigator, Horsens Hospital
ClinicalTrials.gov Identifier: NCT04590924    
Other Study ID Numbers: 1-10-72-1-19
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes