Hip InjuriesNCT04925791
Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
A study testing standardized pre-conditioning treatment and Partial occlusion in people with Hip Injuries and Hip Dislocation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Injuries, Hip Dislocation, Hip Fractures
- What is being tested?
- standardized pre-conditioning treatment and Partial occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Subjects will be asked to take part in one of two treatment procedures 24 hours prior to their scheduled hip arthroscopy date. Subjects will be randomized into either the IPC or CON group.
These treatments consist of either 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion or 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion. The treatment will last 30 minutes. Days 0-7 post-op will consist of self-reported pain scales and opioid consumption documentation in the morning and evening. This is a randomized single-blind research study.
This study has two study groups:
- The IPC group 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.
- The CON group 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.
- Conditions
- Hip Injuries, Hip Dislocation, Hip Fractures
- Being tested
- standardized pre-conditioning treatment, Partial occlusion
- Medical subject headings
- Hip Injuries, Hip Dislocation, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized pre-conditioning treatmentDiagnostic test
3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.
Partial occlusionDiagnostic test
3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Partial occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels VAS score
Pain score 0-10 with 0 being no pain and 10 being the worst
Measured: 7 days post op
Secondary outcomes (1)
number of days opioids were consumed post op
Total number days the patient had to take pain medication
Measured: 7 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start18 Oct 2021
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
- Investigators
- Michael Banffy, MD, Principal investigator, Cedar Sinai -Kerlan Jobe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925791
- Sponsor's protocol ID
- STUDY00001182
- Status last verified
- Aug 2024
- First submitted
- 9 Jun 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40502719
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT04925791
- Acronym / sponsor ID
- STUDY00001182
- Conditions
- Hip Injuries, Hip Dislocation, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be asked to take part in one of two treatment procedures 24 hours prior to their scheduled hip arthroscopy date. Subjects will be randomized into either the IPC or CON group.
These treatments consist of either 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion or 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion. The treatment will last 30 minutes. Days 0-7 post-op will consist of self-reported pain scales and opioid consumption documentation in the morning and evening. This is a randomized single-blind research study.
This study has two study groups:
- The IPC group 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.
- The CON group 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The IPC group | Experimental | Diagnostic Test: standardized pre-conditioning treatmentsubjects 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. |
| The CON group | Other | Diagnostic Test: Partial occlusionsubjects 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized pre-conditioning treatment3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated. | Diagnostic test | The IPC group |
| Partial occlusion3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated. | Diagnostic test | The CON group |
Primary outcome
Pain levels VAS score
Time frame: 7 days post op
Pain score 0-10 with 0 being no pain and 10 being the worst
1 secondary outcome
number of days opioids were consumed post op
Time frame: 7 days post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 40502719Orner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Banffy, MD principal investigator
Cedar Sinai -Kerlan Jobe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized pre-conditioning treatment and Partial occlusion in people with Hip Injuries and Hip Dislocation, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels VAS score (time frame: 7 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.