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

Hip Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03158454
• Other study ID #: Danish EC 1-10-72-279-16
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: Bjarne Mygind-Klavsen, MD
• Phone: +4578467094
• Email: bjarmygi[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Hip Injuries

Intervention

Procedure:
• Capsula Closure
The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures
• Non-Capsula Closure
No capsular closure procedure is performed.

Locations

Country	Name	City	State
Denmark	Division of Sports Trauma, Tage-Hansens Gade 2b	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient reported outcome scores (Hagos)	Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)	From baseline to 2 year after the operation
Secondary	Change in patient reported outcome scores (Ihot12)	Questionnaire - Hip-function Score (0-100)	From baseline to 2 year after the operation
Secondary	Change in patient reported outcome scores (NRS)	Questionnaire - Pain-Score (0-10)	From baseline to 2 year after the operation
Secondary	Change in patient reported outcome scores (EQ5D	Questionnaire - health outcome score.	From baseline to 2 year after the operation
Secondary	Reoperation	revision hip arthroscopy/THA/other)	Up to 2 years after surgery