NCT03768895

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

10 days

First QC Date

December 5, 2018

Last Update Submit

February 15, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Ischiofemoral Space

    the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.

    1 day

  • 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

  • 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

  • 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

Study Arms (1)

MRI group

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.

Radiation: MRI

Interventions

MRIRADIATION

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.

MRI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who had realised a pelvis MRI for any cause at MRI Center in Zaragoza.

You may qualify if:

  • Age \> 18 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dra. Roca Diagnóstico Médico. CEMEDI

Zaragoza, 50006, Spain

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

December 20, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations