Femoro Acetabular Impingement Clinical Trial
Official title:
Pain, Function and Hip Osteoarthritis 5 Years After Hip Arthroscopic Surgery in Patients With Femoroacetabular Impingement
| 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 |
| Verified date | July 2021 |
| Source | Horsens Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Patients included in the HAFAI cohort will be invited for 5 year follow up.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Signe Kierkegaard | Horsens | Danmark |
| Lead Sponsor | Collaborator |
|---|---|
| Horsens Hospital |
Denmark,
| 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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