Long Term Results After Hip Arthroscopy

Femoro Acetabular Impingement Clinical Trial

Official title:

Long Term Results After Hip Arthroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327217
• Other study ID #: OC-2023-009
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Reinier Haga Orthopedisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement

Intervention

Radiation:
• Bilateral hip x-ray
Patients will be asked to visit the clinic for a bilateral hip x-ray, in order to evaluate the degree os osteoarthritis.

Other:
• Questionnaires
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.

Locations

Country	Name	City	State
Netherlands	Reinier Haga Orthopedic Center	Zoetermeer

Sponsors (1)

Lead Sponsor	Collaborator
Reinier Haga Orthopedisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

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