Effect of Post-operative Brace on Pain and Patient Outcom... | NCT05592353

Studies
Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS

NCT05592353

Sponsor

Alexander Weber

Status

Active, not recruiting

Last Update Posted

Nov 18, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hip Arthroscopy

Interventions

Brace

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 19, 2022

First Posted Date

Oct 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The routine application of hip brace following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) has no proven clinical benefits. This study will investigate whether the application of hip brace affects the post-operative course and patient reported outcomes in patients undergoing hip arthroscopy for FAIS.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brace	Active Comparator		Other: Brace
No Brace	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brace	Other	Brace following hip arthroscopy	Brace

Measure	Description	Time Frame
Hip Outcome Score		up to 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age of 18 years or older
Patients with femoroacetabular impingement syndrome (FAIS) and who are candidates for surgical treatment with hip arthroscopy

Exclusion Criteria:

Patient age < 18 years
Patients with FAIS who are not surgical candidates (surgical therapy is not indicated)
Patients with previous, ipsilateral hip procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keck School of Medicine of the University of Southern California		Los Angeles	California	90033	United States

Intervention Browse Module

MeSH Terms

ID	Term
D001915	Braces

Ancestor Terms

ID	Term
D009989	Orthotic Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided