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

Not Applicable

Recruiting

• Conditions: Hip Injuries
• Interventions: Procedure: Non-Capsula Closure; Procedure: Capsula Closure

• Registration Number: NCT03158454
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Study Start: 2017-06-15
• Primary Completion: 2022-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Capsula Closure	Non-Capsula Closure	-
Capsula Closure	Capsula Closure	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Sports Trauma, Tage-Hansens Gade 2b; 🇩🇰 Aarhus, Denmark