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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03768895
Other study ID # MRI center
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 20, 2018
Est. completion date December 30, 2018

Study information

Verified date February 2019
Source Universidad de Zaragoza
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators' objective is the anatomical analysis of hips studied through MRI, assessing their morphological characteristics and correlating them with the pathology found.

A retrospective search was performed using a database of consecutive reports of 137 adults pelvis MRI examinations obtained at MRI center in Zaragoza.

In all the images the investigators are going to measure the ischiofemoral space, quadratus femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated different qualitative changes in the signal intensity of the quadratus femoris muscle as normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or atrophy, too.


Description:

The investigators' objective is the anatomical analysis of hips studied through MRI, assessing their morphological characteristics and correlating them with the pathology found.

A retrospective search was performed using a database of consecutive reports of 137 adults pelvis MRI examinations obtained at MRI center in Zaragoza.

The investigators create a protocol for a retrospective review study, with the aim of analysis all the recorded MRI findings during this time. The criteria for patient inclusion were: Age > 18 years old, who had realised a pelvis MRI for any cause at MRI Center. Exclusion criteria included age < 18 years old, inadequate imaging quality, medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.

In all the images the investigators are going to measure the ischiofemoral space, quadratus femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated different qualitative changes in the signal intensity of the quadratus femoris muscle as normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or atrophy, too.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years old

Exclusion Criteria:

- Age < 18 years old

- Inadequate imaging quality

- Medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.

Study Design


Intervention

Radiation:
MRI
The technique used was coronal and axial T1 and T2*WI sequences of the pelvis and femurs. The MRI machine used is a HITACHI AIRIS-II1 model, with permanent vertical magnetic field of 0.3 Tesla, and the used sequences areT1, T2*WI.

Locations

Country Name City State
Spain Dra. Roca Diagnóstico Médico. CEMEDI Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ischiofemoral Space the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter. 1 day
Primary Quadratus Femoris Space the smallest space for passage of the quadratus femoris muscle delimited by the superolateral surface of the hamstring tendons and the posteromedial surface of the iliopsoas tendón or lesser trochanter. 1 day
Primary Cervicodiaphyseal angle The cervicodiaphyseal angle is formed by the axis of the femoral neck that joins the femoral head with the axis of the femoral shaft. 1 day
Primary Femoral version The femoral version or femoral torsion angle is called the projection on the transverse plane of a longitudinal axis of the femoral neck at the center of the femoral head 1 day
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