Femoro Acetabular Impingement Clinical Trial
Official title:
Long Term Results After Hip Arthroscopy
Verified date | March 2024 |
Source | Reinier Haga Orthopedisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown.
Status | Not yet recruiting |
Enrollment | 451 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | In order to be eligible to participate in this study, a subject must meet all of the following criteria: Inclusion Criteria: - Patient who participated in the cohort study; - At least 5 years of follow up; - Patient is able to understand the meaning of the study and is willing to sign the Informed Consent Form. A potential subject who meets any of the following criteria will be excluded from participation in this study: Exclusion Criteria: - Patient who has had hip arthroscopy of both sides; - Patient is unable or unwilling to sing informed consent |
Country | Name | City | State |
---|---|---|---|
Netherlands | Reinier Haga Orthopedic Center | Zoetermeer |
Lead Sponsor | Collaborator |
---|---|
Reinier Haga Orthopedisch Centrum |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side. | To evaluate the degree of osteoarthritis, the Kellgren and Lawrence-scale will be used.
The scale ranges from 0 to 4: A score of 0 indicates that there is no evidence of osteoarthritis A score of 4 indicates end-stage OA, marked by severe sclerosis, joint space narrowing (sometimes bone-on-bone contact), and large osteophytes. |
5 to 10 years after hip arthroscopy | |
Secondary | To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative. | To evaluate the degree of osteoarthritis, the Kellgren and Lawrence-scale will be used.
The scale ranges from 0 to 4: A score of 0 indicates that there is no evidence of osteoarthritis A score of 4 indicates end-stage OA, marked by severe sclerosis, joint space narrowing (sometimes bone-on-bone contact), and large osteophytes. |
5 to 10 years after hip arthroscopy | |
Secondary | To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy. | survival of the hip arthroscopy (defined by the incidence of total hip replacement) will be presented as a percentage of the total study population. | 5 to 10 years after hip arthroscopy | |
Secondary | To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy. | Functional outcomes measured with patient reported outcome measures (PROMs) at 5 to 10 years after hip arthroscopy. | 5 to 10 years after hip arthroscopy | |
Secondary | To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score. | The scale ranges from 0 to 4:
A score of 0 indicates that there is no evidence of osteoarthritis A score of 4 indicates end-stage OA, marked by severe sclerosis, joint space narrowing (sometimes bone-on-bone contact), and large osteophytes. |
5 to 10 years after hip arthroscopy | |
Secondary | To determine patient satisfaction 5-10 years after hip arthroscopy. | One question on satisfaction will be asked: 'How satisfied are you with the results of the surgery?' on a 10-point scale.
With 0 being not satisfied and 10 being very satisfied. |
5 to 10 years after hip arthroscopy |
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