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Innovative Spinopelvic Solutions with Real-World Evidence

NCT ID: NCT06706908

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-15

Study Completion Date

2034-12-31

Brief Summary

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INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.

Detailed Description

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Conditions

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Sacroiliac Joint Dysfunction Sacroiliac Joint Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Health questionnaires

Participants are expected to complete a series of health questionnaires (i.e. numerical rating scale, Oswestry Disability Index) relevant to their treatment using a SI-BONE implant.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \> 21 at time of screening.
2. Patient will undergo a procedure utilizing an iFuse Implant family product.
3. Patient is comfortable communicating in written and spoken English.
4. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
5. Patient is willing and able to provide informed consent to participate

Exclusion Criteria

1. Patient has fibromyalgia.
2. Patient has a pain pump.
3. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SI-BONE, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robyn Capobianco, PhD

Role: PRINCIPAL_INVESTIGATOR

SI-BONE

Locations

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SI-BONE

Santa Clara, California, United States

Site Status

Countries

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United States

Other Identifiers

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302022

Identifier Type: -

Identifier Source: org_study_id