NCT03105063

Brief Summary

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 28, 2017

Last Update Submit

April 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • AIIS morpholgy

    AIIS morphology is determined according to the hetzroni classification

    through study completion, an average of 1 year

Study Arms (1)

US GROUP

EXPERIMENTAL

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

Diagnostic Test: ultrasound scan of the hip

Interventions

validation of Ultrasound test as a tool for diagosing AIIS morphology

US GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to
  • hip related complaints

You may not qualify if:

  • Patient refusal
  • Inability to consent
  • Unavailable 3d imaging the hip joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24140143BACKGROUND
  • 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.

    PMID: 24793210BACKGROUND
  • 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.

    PMID: 26589837BACKGROUND

Central Study Contacts

Ran a ankory, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 7, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

December 1, 2019

Last Updated

April 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share