NCT05592353

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 8, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.2 years

First QC Date

October 19, 2022

Last Update Submit

November 17, 2023

Conditions

Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Hip Outcome Score

    up to 1 year

Study Arms (2)

Brace

ACTIVE COMPARATOR
Other: Brace

No Brace

NO INTERVENTION

Interventions

BraceOTHER

Brace following hip arthroscopy

Brace

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

October 8, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

US(1)