HealthyNCT04687306
Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts
An observational study of Healthy, run by University of Nebraska at 1 site in United States.
Trial summary
Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- X-rays- total of 4
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 31 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries
Who may be able to join
- Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries
Who cannot join
- no history of spine/hip/pelvis issues
- females who are trying to get pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68918
About this study
Official title: Inter-observer Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on Anteroposterior Pelvic Radiographs in Healthy Individuals.
Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.
Read the detailed description
The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.
This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.
- Conditions
- Healthy
- Being tested
- X-rays- total of 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rays- total of 4Diagnostic test
X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
| Study group | Role | What they receive |
|---|---|---|
| Females | 15 females Receives: Diagnostic Test: X-rays- total of 4 | |
| Males | 15 Males Receives: Diagnostic Test: X-rays- total of 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.
Intraclass correlation coefficient (ICC) was used to assess [inter-rater/intra-rater/test-retest] reliability. ICC values range from 0 to 1, where values closer to 1 indicate stronger agreement and values closer to 0 indicate weaker agreement, will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.
Measured: At study visit for up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Jan 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin L Garvin, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687306
- Sponsor's protocol ID
- 0719-20-FB
- Status last verified
- Sep 2024
- First submitted
- 2 Dec 2020
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-observer Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on Anteroposterior Pelvic Radiographs in Healthy Individuals.
- ClinicalTrials.gov ID
- NCT04687306
- Acronym / sponsor ID
- 0719-20-FB
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.
Detailed description
The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.
This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females | – | Diagnostic Test: X-rays- total of 415 females |
| Males | – | Diagnostic Test: X-rays- total of 415 Males |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries
Key inclusion criteria (1 listed)
- Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries
Key exclusion criteria (2 listed)
- no history of spine/hip/pelvis issues
- females who are trying to get pregnant
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 |
|---|---|---|
| X-rays- total of 4X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions | Diagnostic test | Females, Males |
Primary outcome
Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.
Time frame: At study visit for up to 1 hour
Intraclass correlation coefficient (ICC) was used to assess [inter-rater/intra-rater/test-retest] reliability. ICC values range from 0 to 1, where values closer to 1 indicate stronger agreement and values closer to 0 indicate weaker agreement, will be used to evaluate the consistency of the 4 providers in measuring the sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kevin L Garvin, MD principal investigator
University of Nebraska
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 Healthy, run by University of Nebraska at 1 site in United States.
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 2 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 26 May 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraclass Correlation Coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements. (time frame: At study visit for up to 1 hour). 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 26 May 2026.