Arthroscopic Iliopsoas ReleaseNCT01763372
Functional Implications of Arthroscopic Iliopsoas Release
An observational study of Arthroscopic Iliopsoas Release, run by University of Utah.
Trial summary
The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthroscopic Iliopsoas Release
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Feb 2016
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing arthroscopic surgery by Dr. Aoki, divided into two groups: Those undergoing arthroscopic psoas release, and those undergoing arthroscopic surgery without psoas release,
Who may be able to join
- All subjects will be greater than 18 years of age.
- We will recruit 18 subjects who have undergone arthroscopic iliopsoas release by Dr. Aoki.
- We will recruit 18 additional subjects that had hip arthroscopy with Dr. Aoki without iliopsoas release to serve as a control group.
Who cannot join
- As the nonoperative contralateral hip will serve as a control to the operative hip, we will exclude patients for this study who have undergone bilateral procedures.
- We will exclude any patients who are not comfortable with the MRI scan, stationary bike or strength testing.
About this study
The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. To delineate the effects of arthroscopic surgery alone from those resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a second control group consisting of patients who have undergone arthroscopic surgery by Dr. Aoki without iliopsoas release.
For both hips of each subject, we will:
Read more
- Quantify the muscle volume of the iliopsoas muscle with MRI.
- Quantify hip flexion strength with isokinetic dynamometry.
- Quantify patient function and satisfaction with functional outcome surveys.
This data will allow us to test the following hypotheses:
- Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
- Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
- Patient function and satisfaction positively correlates to muscle bulk and strength.
- Conditions
- Arthroscopic Iliopsoas Release
- Keywords
- Arthroscopic, Iliopsoas, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Volume
Measured: 1 yr post op
Secondary outcomes (1)
Hip Flexion Strength
Measured: 1 yr post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Iliopsoas ReleaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Aoki, University of Utah
- Investigators
- Stephen Aoki, Principal investigator, Orthopedic Surgery Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763372
- Sponsor's protocol ID
- 58424
- Status last verified
- Aug 2016
- First submitted
- 4 Jan 2013
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Implications of Arthroscopic Iliopsoas Release
- ClinicalTrials.gov ID
- NCT01763372
- Acronym / sponsor ID
- 58424
- Conditions
- Arthroscopic Iliopsoas Release
- Keywords
- Arthroscopic, Iliopsoas, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2013 (estimated)
- 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 investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. To delineate the effects of arthroscopic surgery alone from those resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a second control group consisting of patients who have undergone arthroscopic surgery by Dr. Aoki without iliopsoas release.
For both hips of each subject, we will:
- Quantify the muscle volume of the iliopsoas muscle with MRI.
- Quantify hip flexion strength with isokinetic dynamometry.
- Quantify patient function and satisfaction with functional outcome surveys.
This data will allow us to test the following hypotheses:
- Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
- Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
- Patient function and satisfaction positively correlates to muscle bulk and strength.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing arthroscopic surgery by Dr. Aoki, divided into two groups: Those undergoing arthroscopic psoas release, and those undergoing arthroscopic surgery without psoas release,
Key inclusion criteria (3 listed)
- All subjects will be greater than 18 years of age.
- We will recruit 18 subjects who have undergone arthroscopic iliopsoas release by Dr. Aoki.
- We will recruit 18 additional subjects that had hip arthroscopy with Dr. Aoki without iliopsoas release to serve as a control group.
Key exclusion criteria (2 listed)
- As the nonoperative contralateral hip will serve as a control to the operative hip, we will exclude patients for this study who have undergone bilateral procedures.
- We will exclude any patients who are not comfortable with the MRI scan, stationary bike or strength testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Volume
Time frame: 1 yr post op
1 secondary outcome
Hip Flexion Strength
Time frame: 1 yr 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 15 Aug 2016.
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.
Stephen Aoki principal investigator
Orthopedic Surgery Operations
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopic Iliopsoas Release, run by University of Utah.
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 3 inclusion and 2 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscle Volume (time frame: 1 yr post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2016.