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

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ClinicalTrials.gov Identifier: NCT03158454
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Lind, Aarhus University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Injuries Procedure: Capsula Closure Procedure: Non-Capsula Closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Capsula Closure Procedure: Capsula Closure
The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures

Non-Capsula Closure Procedure: Non-Capsula Closure
No capsular closure procedure is performed.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in patient reported outcome scores (Ihot12) [ Time Frame: From baseline to 2 year after the operation ]
    Questionnaire - Hip-function Score (0-100)

  2. Change in patient reported outcome scores (NRS) [ Time Frame: From baseline to 2 year after the operation ]
    Questionnaire - Pain-Score (0-10)

  3. Change in patient reported outcome scores (EQ5D [ Time Frame: From baseline to 2 year after the operation ]
    Questionnaire - health outcome score.

  4. Reoperation [ Time Frame: Up to 2 years after surgery ]
    revision hip arthroscopy/THA/other)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158454


Contacts
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Contact: Bjarne Mygind-Klavsen, MD +4578467094 bjarmygi@rm.dk
Contact: Torsten Nielsen, PT +4578467094 torsne@rm.dk

Locations
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Denmark
Division of Sports Trauma, Tage-Hansens Gade 2b Recruiting
Aarhus, Denmark, 8000
Contact: Martin Lind, Professor       martli@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Lind, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03158454     History of Changes
Other Study ID Numbers: Danish EC 1-10-72-279-16
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Femoracetabular Impingement
Hip Injuries
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Wounds and Injuries