Femoro Acetabular ImpingementNCT06327217
Long Term Results After Hip Arthroscopy
An observational study of Femoro Acetabular Impingement, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- Bilateral hip x-ray and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 451 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 1 Mar 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from a previous hip arthroscopy cohort study, who are between 5 and 10 years of follow-up.
Who may be able to join
- 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:
Who cannot join
- Patient who has had hip arthroscopy of both sides;
- Patient is unable or unwilling to sing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- Bilateral hip x-ray, Questionnaires
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral hip x-rayRadiation
Patients will be asked to visit the clinic for a bilateral hip x-ray, in order to evaluate the degree os osteoarthritis.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hip arthroscopy 5-10jr | Not described Receives: Radiation: Bilateral hip x-ray; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 to 10 years after hip arthroscopy
Secondary outcomes (5)
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.
Measured: 5 to 10 years after hip arthroscopy
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.
Measured: 5 to 10 years after hip arthroscopy
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.
Measured: 5 to 10 years after hip arthroscopy
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.
Measured: 5 to 10 years after hip arthroscopy
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.
Measured: 5 to 10 years after hip arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327217
- Sponsor's protocol ID
- OC-2023-009
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT06327217
- Acronym / sponsor ID
- OC-2023-009
- Conditions
- Femoro Acetabular Impingement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 451 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip arthroscopy 5-10jr | – | Radiation: Bilateral hip x-ray, Other: Questionnaires |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from a previous hip arthroscopy cohort study, who are between 5 and 10 years of follow-up.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- Patient who has had hip arthroscopy of both sides;
- Patient is unable or unwilling to sing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral hip x-rayPatients will be asked to visit the clinic for a bilateral hip x-ray, in order to evaluate the degree os osteoarthritis. | Radiation | Hip arthroscopy 5-10jr |
| QuestionnairesPatients 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. | Other | Hip arthroscopy 5-10jr |
Primary outcome
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 secondary outcomes
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 report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy.
Time frame: 5 to 10 years after hip arthroscopy
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
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
To determine patient satisfaction 5-10 years after hip arthroscopy.
Time frame: 5 to 10 years after hip arthroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoro Acetabular Impingement, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.