Hip Pain ChronicNCT03768895
Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found
An observational study of Hip Pain Chronic and Musculoskeletal Disease, run by Universidad de Zaragoza at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Pain Chronic, Musculoskeletal Disease, Femoral Anteversion
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2018to 30 Dec 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: People who had realised a pelvis MRI for any cause at MRI Center in Zaragoza.
Who may be able to join
- Age > 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- MRI
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischiofemoral Space
the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start20 Dec 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pilar López Royo, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768895
- Sponsor's protocol ID
- MRI center
- Status last verified
- Feb 2019
- First submitted
- 5 Dec 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found
- ClinicalTrials.gov ID
- NCT03768895
- Acronym / sponsor ID
- MRI center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 7 Dec 2018 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI group | – | Radiation: MRIThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who had realised a pelvis MRI for any cause at MRI Center in Zaragoza.
Key inclusion criteria (1 listed)
- Age > 18 years old
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| MRIThe 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. | Radiation | MRI group |
Primary outcome
Ischiofemoral Space
Time frame: 1 day
the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.
Quadratus Femoris Space
Time frame: 1 day
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.
Cervicodiaphyseal angle
Time frame: 1 day
The cervicodiaphyseal angle is formed by the axis of the femoral neck that joins the femoral head with the axis of the femoral shaft.
Femoral version
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Pain Chronic and Musculoskeletal Disease, run by Universidad de Zaragoza at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischiofemoral Space (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2019.