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standardized pre-conditioning treatment for Hip Dislocation

N/A
Waitlist Available
Led By Michael Banffy, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post op
Awards & highlights

Study Summary

This trial will test whether using ischemic pre-conditioning—a technique that temporarily cuts off blood flow to an area of the body—24 hours before a hip arthroscopy can decrease patients' post-operative pain and need for painkillers.

Who is the study for?
This trial is for individuals aged 18 to 55 who are scheduled for their first hip arthroscopy. It's not suitable for those on blood clot risk-increasing meds, anyone outside the age range, or with a history of venous thromboembolism or previous hip surgeries.Check my eligibility
What is being tested?
The study tests if Ischemic Pre-Conditioning (partially blocking blood flow) one day before surgery can lessen pain and reduce opioid use after hip arthroscopy compared to standard treatment without pre-conditioning.See study design
What are the potential side effects?
While specific side effects aren't listed, ischemic pre-conditioning may cause discomfort due to restricted blood flow or potential bruising at the site of occlusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old and scheduled for a first-time hip arthroscopy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain levels VAS score
Secondary outcome measures
number of days opioids were consumed post op

Trial Design

2Treatment groups
Experimental Treatment
Group I: The IPC groupExperimental Treatment1 Intervention
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.
Group II: The CON groupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,789 Total Patients Enrolled
Michael Banffy, MD3.931 ReviewsPrincipal Investigator - Cedar Sinai -Kerlan Jobe
Cedars-Sinai Medical Center
2 Previous Clinical Trials
92 Total Patients Enrolled
2Patient Review
I was extremely disappointed with my experience with Dr. Banffy. He was dismissive of my concerns and failed to provide any clear guidance on how to move forward with my treatment. His office staff was also unresponsive to my requests for information. I would not recommend him to anyone.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort receiving treatment through this research program?

"Affirmative. According to the clinicaltrials.gov portal, this trial has opened up recruitment on August 11th 2021 and is actively looking for 68 patients at a single site. The details of the project were last refreshed on June 9th 2021."

Answered by AI

What type of participants are best suited for this medical experiment?

"This medical trial is accepting 68 participants with diagnoses of hip dysplasia and ages between 18-55."

Answered by AI

Are there any remaining openings in this investigation for volunteers?

"As per the clinicaltrials.gov, this medical trial is seeking participants with a posting date of August 11th 2021 and most recently updated on June 9th 2021."

Answered by AI

Is the upper age limit for this trial beyond 40 years?

"Adolescents aged 18 and adults up to 55 are eligible for enrolment in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Michael Banffy, MD 2021. "Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925791.
~0 spots leftby May 2024
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