Functional Implications of Arthroscopic Iliopsoas Release

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
ClinicalTrials.gov Identifier:
NCT01763372
First received: January 4, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.

Condition
Arthroscopic Iliopsoas Release

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Functional Implications of Arthroscopic Iliopsoas Release

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Muscle Volume [ Time Frame: 1 yr post op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hip Flexion Strength [ Time Frame: 1 yr post op ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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,

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763372

Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Stephen Aoki Orthopedic Surgery Operations
  More Information

No publications provided

Responsible Party: Stephen Aoki, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01763372     History of Changes
Other Study ID Numbers: 58424
Study First Received: January 4, 2013
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Arthroscopic
Iliopsoas
MRI

ClinicalTrials.gov processed this record on July 24, 2014