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

• Sponsor: Alexander Weber (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05592353
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthroscopy	Other: Brace	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS: A Randomized Study
• Actual Study Start Date: Oct 8, 2022
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Brace	Other: Brace; Brace following hip arthroscopy
No Intervention: No Brace

Outcome Measures

Primary Outcome Measures

1. HOS ADL [up to 1 year]

   Hip Outcome Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck School of Medicine of the University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• Alexander Weber

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander Weber, Assistant Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT05592353
• Other Study ID Numbers: HS-20-00060
• First Posted: Oct 24, 2022
• Last Update Posted: Oct 24, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 24, 2022