Long Term Results After Hip Arthroscopy

March 20, 2024 updated by: Reinier Haga Orthopedisch Centrum
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 Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

451

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zoetermeer, Netherlands, 2725 NA
        • Reinier Haga Orthopedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • OC-2023-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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