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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04590924
Other study ID # 1-10-72-1-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date June 30, 2021

Study information

Verified date July 2021
Source Horsens Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Included in the HAFAI cohort Exclusion Criteria: - Non

Study Design


Intervention

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

Locations

Country Name City State
Denmark Signe Kierkegaard Horsens Danmark

Sponsors (1)

Lead Sponsor Collaborator
Horsens Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 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
Primary Sports function 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
Primary Development of osteoarthritis 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
Primary Re-operation 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 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) Score at 5 years and change from before surgery to 5 years after surgery
Secondary 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) Score at 5 years and change from before surgery to 5 years after surgery
Secondary 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) Score at 5 years and change from before surgery to 5 years after surgery
Secondary Participation in sport 5 years after surgery (HSAS) 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
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