Long Term Results After Hip Arthroscopy

NCT06327217 | Not Yet Recruiting

• 1 other identifier: OC-2023-009
• Study Type: observational
• Target: 451
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femoro Acetabular Impingement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative.

  5 to 10 years after hip arthroscopy

• To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy.

  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.

  5 to 10 years after hip arthroscopy

• To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score.

  5 to 10 years after hip arthroscopy

• To determine patient satisfaction 5-10 years after hip arthroscopy.

  5 to 10 years after hip arthroscopy

Study Arms (1)

Hip arthroscopy 5-10jr

Radiation: Bilateral hip x-ray; Other: Questionnaires

Interventions

Bilateral hip x-ray RADIATION

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

Hip arthroscopy 5-10jr

Questionnaires OTHER

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.

Hip arthroscopy 5-10jr

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from a previous hip arthroscopy cohort study, who are between 5 and 10 years of follow-up.

You may qualify if:

• 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:

You may not qualify if:

• Patient who has had hip arthroscopy of both sides;
• Patient is unable or unwilling to sing informed consent

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead

Study Sites (1)

Reinier Haga Orthopedic Center

Zoetermeer, 2725 NA, Netherlands

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

NL (1)