Spinopelvic Relationships as They Relate to Total Hip Arthroplasty'sNCT05117229

Correlation of Spinopelvic Movement With Lateral Radiographs

A study testing MetaWear Sensor in people with Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
What is being tested?: MetaWear Sensor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2021to 19 Jan 2023
Phase: Interventional
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide informed consent.
Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.

Who cannot join

Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty

The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.

Conditions: Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
Being tested: MetaWear Sensor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetaWear SensorDevice
Sensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken

Study groups in NCT05117229
Study group	Role	What they receive
MetaWear Sensor on radiograph	Experimental	subjects being considered for surgical orthopedic surgery will have a MetaWear sensor added to their standard of care lateral sit to stand radiograph Receives: Device: MetaWear Sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

Pelvic Tilt (PT)
PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees.
Measured: Baseline
Sacral Slope (SS)
Sacral slope (SS) is a position-dependent parameter defined as the angle between a line parallel to the sacral end plate and a horizontal line. As recorded by theMetaWear sensor reported in degrees.
Measured: Baseline
Pelvic Incidence (PI)
PI is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting the same point to the center of the bicoxofemoral axis. As recorded by theMetaWear sensor reported in degrees.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202119 Jan 2023

First posted11 Nov 2021
Study start1 Dec 2021
Primary completion19 Jan 2023
Study completion19 Jan 2023

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 Spinopelvic Relationships as They Relate to Total Hip Arthroplasty'sStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: All participants will have the MetaWear Sensors used on them
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05117229
Sponsor's protocol ID: 21-006428
Status last verified: Oct 2023
First submitted: 1 Nov 2021
Last updated: 18 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation of Spinopelvic Movement With Lateral Radiographs to Assess Spine Motion Prior to Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT05117229
Acronym / sponsor ID: 21-006428
Conditions: Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Dec 2021 (actual)
Primary completion: 19 Jan 2023 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 11 Nov 2021 (actual)
Results: Posted 18 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will have the MetaWear Sensors used on them

Arm	Type	Receives
MetaWear Sensor on radiograph	Experimental	Device: MetaWear Sensorsubjects being considered for surgical orthopedic surgery will have a MetaWear sensor added to their standard of care lateral sit to stand radiograph

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Ability to provide informed consent.
Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.

Key exclusion criteria (1 listed)

Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.

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
MetaWear SensorSensor placed on the pelvis to record spinopelvic movement. Lateral sitting and standing lumbar radiographs will be taken	Device	MetaWear Sensor on radiograph

Primary outcome

Pelvic Tilt (PT)
Time frame: Baseline
PT is a position dependent parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and vertical axis. As recorded by theMetaWear sensor reported in degrees.
Sacral Slope (SS)
Time frame: Baseline
Sacral slope (SS) is a position-dependent parameter defined as the angle between a line parallel to the sacral end plate and a horizontal line. As recorded by theMetaWear sensor reported in degrees.
Pelvic Incidence (PI)
Time frame: Baseline
PI is defined as the angle between a line perpendicular to the sacral plate at its midpoint and a line connecting the same point to the center of the bicoxofemoral axis. As recorded by theMetaWear sensor reported in degrees.

Results and safety

Results posted to the registry on 18 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MetaWear Sensor on Radiograph	40	40

Primary outcome: Pelvic Tilt (PT)

Time frame: Baseline. Mean (Standard Deviation). Unit: degrees

Measure	MetaWear Sensor on Radiograph n = 40
Sitting	40.0 (11.9)
Standing	20.0 (10.5)

Primary outcome: Sacral Slope (SS)

Time frame: Baseline. Mean (Standard Deviation). Unit: degrees

Measure	MetaWear Sensor on Radiograph n = 40
Sitting	16.2 (11.0)
Standing	33.2 (11.34)

Primary outcome: Pelvic Incidence (PI)

Time frame: Baseline. Mean (Standard Deviation). Unit: degrees

Measure	MetaWear Sensor on Radiograph n = 40
Value	52.0 (12.6)

Adverse events

Time frame: Adverse events were collected from baseline to end of study, approximately one day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MetaWear Sensor on Radiograph	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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.

Rafael J Sierra, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MetaWear Sensor in people with Spinopelvic Relationships as They Relate to Total Hip Arthroplasty's, run by Mayo Clinic 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 2 inclusion and 1 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 18 Nov 2023. 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 18 Nov 2023). 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?

Pelvic Tilt (PT) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05117229.

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 18 Nov 2023.