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

N/AActive Not RecruitingNCT03158454

Aarhus University Hospital200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

200

Conditions

Hip Injuries

Interventions

Capsula ClosurePROCEDURE

The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures

Non-Capsula ClosurePROCEDURE

No capsular closure procedure is performed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Sports Trauma, Tage-Hansens Gade 2b

Aarhus, Denmark

Outcomes

Primary Outcomes

Change in patient reported outcome scores (Hagos)

Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)

Time frame: From baseline to 2 year after the operation

Secondary Outcomes

Change in patient reported outcome scores (Ihot12)

Questionnaire - Hip-function Score (0-100)

Time frame: From baseline to 2 year after the operation

Change in patient reported outcome scores (NRS)

Questionnaire - Pain-Score (0-10)

Time frame: From baseline to 2 year after the operation

Change in patient reported outcome scores (EQ5D

Questionnaire - health outcome score.

Time frame: From baseline to 2 year after the operation

Reoperation

revision hip arthroscopy/THA/other)

Time frame: Up to 2 years after surgery

Data from ClinicalTrials.gov

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