- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105063
Evaluation of the AIIS Using Hip Ultrasound(AIISUS) (AIISUS)
The anatomy of the acetabulum is well described in the past literature, yet the understanding of the clinical importance of the anatomical morphology of the AIIS has grown in recent years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this classification, three types AIIS are identified based on the relationship between the distal extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the AIIS using standard AP pelvis examination is misleading and requires additional imagery, a specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT or MRI.
The objective of this study is to evaluate AIIS morphology using ultrasound as compared to golden standard (MRI)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to
hip related complaints
Exclusion Criteria:
Patient refusal
- Inability to consent
- Unavailable 3d imaging the hip joint
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: US GROUP
All patients will first undergo ultrasound scan of the hip in attempt to recognize the AIIS, on the same day , the true morphology of the AIIS will be evaluated using 3d imaging
|
validation of Ultrasound test as a tool for diagosing AIIS morphology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AIIS morpholgy
Time Frame: through study completion, an average of 1 year
|
AIIS morphology is determined according to the hetzroni classification
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hapa O, Bedi A, Gursan O, Akar MS, Guvencer M, Havitcioglu H, Larson CM. Anatomic footprint of the direct head of the rectus femoris origin: cadaveric study and clinical series of hips after arthroscopic anterior inferior iliac spine/subspine decompression. Arthroscopy. 2013 Dec;29(12):1932-40. doi: 10.1016/j.arthro.2013.08.023. Epub 2013 Oct 18.
- Ryan JM, Harris JD, Graham WC, Virk SS, Ellis TJ. Origin of the direct and reflected head of the rectus femoris: an anatomic study. Arthroscopy. 2014 Jul;30(7):796-802. doi: 10.1016/j.arthro.2014.03.003. Epub 2014 May 2.
- Lee WA, Saroki AJ, Loken S, Trindade CA, Cram TR, Schindler BR, LaPrade RF, Philippon MJ. Radiographic Identification of Arthroscopically Relevant Acetabular Structures. Am J Sports Med. 2016 Jan;44(1):67-73. doi: 10.1177/0363546515612083. Epub 2015 Nov 20.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TASMC-17-RA-846-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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