- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327217
Long Term Results After Hip Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Zoetermeer, Netherlands, 2725 NA
- Reinier Haga Orthopedic Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hip arthroscopy 5-10jr
|
Patients will be asked to visit the clinic for a bilateral hip x-ray, in order to evaluate the degree os osteoarthritis.
Patients will be asked to complete questionnaires on function, quality of life and pain (the modified Harris Hip Score (mHHS), Hip Outcome Score (HOS), the World Health Organisation Quality of Life Questionnaire (WHOWOL) and Visual Analogue Scale (VAS) for pain).
One question will be asked: 'How satisfied are you with the results of the surgery?' on a 10-point scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side.
Time Frame: 5 to 10 years after hip arthroscopy
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative.
Time Frame: 5 to 10 years after hip arthroscopy
|
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
|
|
To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy.
Time Frame: 5 to 10 years after 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
|
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To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy.
Time Frame: 5 to 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
|
|
To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score.
Time Frame: 5 to 10 years after hip arthroscopy
|
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
|
|
To determine patient satisfaction 5-10 years after hip arthroscopy.
Time Frame: 5 to 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OC-2023-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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