- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763372
Functional Implications of Arthroscopic Iliopsoas Release
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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,
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle Volume
Time Frame: 1 yr post op
|
1 yr post op
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hip Flexion Strength
Time Frame: 1 yr post op
|
1 yr post op
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Aoki, Orthopedic Surgery Operations
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 58424
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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