Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

September 30, 2025 updated by: Martin Lind, Aarhus University Hospital

Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

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

  • Denmark
      • Aarhus, Denmark, 8000
        • Division of Sports Trauma, Tage-Hansens Gade 2b

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.

Exclusion Criteria:

  • Previous hip surgery in either hip
  • Malignant disease
  • Recent hip or pelvic fractures
  • Arthritic disease
  • Hip joint dysplasia
  • Legg-Calvé-Perthes
  • Slipped Capital Femoris Epiphysis
  • Recent (within 6 weeks) medical treatment with corticosteroids
  • Language problems of any kind

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Capsula Closure
Procedure: Capsula Closure
The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures
Other: Non-Capsula Closure
Procedure: Non-Capsula Closure
No capsular closure procedure is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported outcome scores (Hagos)
Time Frame: From baseline to 2 year after the operation
Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)
From baseline to 2 year after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported outcome scores (Ihot12)
Time Frame: From baseline to 2 year after the operation
Questionnaire - Hip-function Score (0-100)
From baseline to 2 year after the operation
Change in patient reported outcome scores (NRS)
Time Frame: From baseline to 2 year after the operation
Questionnaire - Pain-Score (0-10)
From baseline to 2 year after the operation
Change in patient reported outcome scores (EQ5D
Time Frame: From baseline to 2 year after the operation
Questionnaire - health outcome score.
From baseline to 2 year after the operation
Reoperation
Time Frame: Up to 2 years after surgery
revision hip arthroscopy/THA/other)
Up to 2 years after surgery

Collaborators and Investigators

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

Sponsor

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 15, 2017

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish EC 1-10-72-279-16

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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