NCT04925791

Brief Summary

The purpose of this study is to determine if the utilization of Ischemic Pre-Conditioning 24-hours prior to hip arthroscopy decreases patient's post-operative pain and opioid consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

June 9, 2021

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain levels VAS score

    Pain score 0-10 with 0 being no pain and 10 being the worst

    7 days post op

Secondary Outcomes (1)

  • number of days opioids were consumed post op

    7 days post op

Study Arms (2)

The IPC group

EXPERIMENTAL

subjects will get a standardized pre-conditioning treatment 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion while seated.

Diagnostic Test: standardized pre-conditioning treatment

The CON group

OTHER

subjects will get a controlled treatment of 20% of limb occlusion pressure 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion while seated.

Diagnostic Test: Partial occlusion

Interventions

3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.

The IPC group
Partial occlusionDIAGNOSTIC_TEST

3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.

The CON group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.

You may not qualify if:

  • Patients younger than 18 or older than 55 who have had a previous hip arthroscopy, venous thromboembolism, and/or who take medications and/or supplements known to increase the risk of blood clots.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerlan Jobe

Los Angeles, California, 90045, United States

Location

Related Publications (1)

  • Orner C, Usoro A, Bergeron B, Banffy M. Does Ischemic Preconditioning of the Operative Limb Reduce Pain After Hip Arthroscopy? A Prospective, Single-Blind, Randomized Controlled Trial. Orthop J Sports Med. 2025 Jun 10;13(6):23259671251343762. doi: 10.1177/23259671251343762. eCollection 2025 Jun.

MeSH Terms

Conditions

Hip InjuriesHip DislocationHip Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DislocationsJoint DiseasesMusculoskeletal DiseasesFemoral FracturesFractures, BoneLeg Injuries

Study Officials

  • Michael Banffy, MD

    Cedar Sinai -Kerlan Jobe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 14, 2021

Study Start

October 18, 2021

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations