AISAIISUSNCT03105063
Evaluation of the AIIS Using Hip Ultrasound(AIISUS)
A study testing ultrasound scan of the hip in people with AIS, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AIS
- What is being tested?
- ultrasound scan of the hip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to
- hip related complaints
Who cannot join
- Patient refusal
- Inability to consent
- Unavailable 3d imaging the hip joint
Trial locations and contacts
No sites are listed yet.
About this study
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)
- Conditions
- AIS
- Being tested
- ultrasound scan of the hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound scan of the hipDiagnostic test
validation of Ultrasound test as a tool for diagosing AIIS morphology
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: ultrasound scan of the hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIIS morpholgy
AIIS morphology is determined according to the hetzroni classification
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AISStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105063
- Sponsor's protocol ID
- TASMC-17-RA-846-CTIL
- Acronym
- AIISUS
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24140143Ryan 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.
PubMed 24793210Lee 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.
PubMed 26589837
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the AIIS Using Hip Ultrasound(AIISUS)
- ClinicalTrials.gov ID
- NCT03105063
- Acronym / sponsor ID
- AIISUS / TASMC-17-RA-846-CTIL
- Conditions
- AIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Apr 2017 (actual)
- 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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US GROUP | Experimental | Diagnostic Test: ultrasound scan of the hipAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to
- hip related complaints
Key exclusion criteria (3 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound scan of the hipvalidation of Ultrasound test as a tool for diagosing AIIS morphology | Diagnostic test | US GROUP |
Primary outcome
AIIS morpholgy
Time frame: through study completion, an average of 1 year
AIIS morphology is determined according to the hetzroni classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Background: PubMed 24140143Hapa 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.
- Background: PubMed 24793210Ryan 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.
- Background: PubMed 26589837Lee 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.
- Individual participant dataSharing planned: No
Related trials for AIS
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
RecruitingPhase 2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer
RecruitingPhase 3
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Prostate Cancer, mHSPC
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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound scan of the hip in people with AIS, run by Tel-Aviv Sourasky Medical Center.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran a ankory, MD (052-4262102, ranankory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIIS morpholgy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105063, which also lists 3 linked publications.
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 7 Apr 2017.