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

Primary Purpose

Hip Injuries

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Capsula Closure

Non-Capsula Closure

About this trial

This is an interventional health services research trial for Hip Injuries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Sports Trauma, Tage-Hansens Gade 2bRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Capsula Closure

Non-Capsula Closure

Arm Description

Outcomes

Primary Outcome Measures

Change in patient reported outcome scores (Hagos)

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

Secondary Outcome Measures

Change in patient reported outcome scores (Ihot12)

Questionnaire - Hip-function Score (0-100)

Change in patient reported outcome scores (NRS)

Questionnaire - Pain-Score (0-10)

Change in patient reported outcome scores (EQ5D

Questionnaire - health outcome score.

Reoperation

revision hip arthroscopy/THA/other)

Full Information

NCT ID

NCT03158454

First Posted

May 15, 2017

Last Updated

January 5, 2023

Sponsor

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03158454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Injuries

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capsula Closure

Arm Type

Other

Arm Title

Non-Capsula Closure

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

Capsula Closure

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Non-Capsula Closure

Intervention Description

No capsular closure procedure is performed.

Primary Outcome Measure Information:

Title

Change in patient reported outcome scores (Hagos)

Description

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

Time Frame

From baseline to 2 year after the operation

Secondary Outcome Measure Information:

Title

Change in patient reported outcome scores (Ihot12)

Description

Questionnaire - Hip-function Score (0-100)

Time Frame

From baseline to 2 year after the operation

Title

Change in patient reported outcome scores (NRS)

Description

Questionnaire - Pain-Score (0-10)

Time Frame

From baseline to 2 year after the operation

Title

Change in patient reported outcome scores (EQ5D

Description

Questionnaire - health outcome score.

Time Frame

From baseline to 2 year after the operation

Title

Reoperation

Description

revision hip arthroscopy/THA/other)

Time Frame

Up to 2 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bjarne Mygind-Klavsen, MD

Phone

+4578467094

bjarmygi@rm.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Torsten Nielsen, PT

Phone

+4578467094

torsne@rm.dk

Facility Information:

Facility Name

Division of Sports Trauma, Tage-Hansens Gade 2b

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Lind, Professor

martli@rm.dk

12. IPD Sharing Statement

Citations:

PubMed Identifier

29440159

Citation

Dippmann C, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Briggs K, Philippon M, Mygind-Klavsen B. Multicentre study on capsular closure versus non-capsular closure during hip arthroscopy in Danish patients with femoroacetabular impingement (FAI): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 10;8(2):e019176. doi: 10.1136/bmjopen-2017-019176.

Results Reference

derived

Learn more about this trial

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

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