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NCT05438719 · ClinicalTrials.gov registry record · NA

MOTUS Total Joint Replacement Investigational Device Exemption Study

A NA study of Lumbar Spine Degeneration, sponsored by 3Spine.

Active
Registry status
NA
Development phase
158
Enrollment target
14
Study locations

NCT05438719 is a NA study of Lumbar Spine Degeneration that is active but no longer recruiting, run by 3Spine. The registered enrollment target is 158 participants, below the 621-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (75% lower). The trial reports 14 study locations across 12 states.

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The verdict

NCT05438719, a NA study of Lumbar Spine Degeneration, is active but no longer recruiting, sponsored by 3Spine.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
158 participants
Enrollment target
14
Study locations

Study Summary

This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.

Conditions Studied

Interventions

  • DEVICE MOTUS Total Joint Replacement

Study Locations (14)

Florida

  • Spine an Orthopedic Center - Deerfield Beach
  • Florida Orthopaedic Institute - Temple Terrace

New York

  • Upstate Ortho - East Syracuse
  • NYU Langone - New York

California

  • Todd H. Lanman, MD Inc. - Los Angeles

Colorado

  • Steamboat Orthopaedic & Spine Institute (SOSI) - Steamboat Springs

Kentucky

  • Strenge Spine Institute - Paducah

Louisiana

  • Spine Institute of Louisiana - Shreveport

Minnesota

  • Mayo Clinic - Rochester

North Carolina

  • Pinehurst Surgical Clinic - Pinehurst

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2022-06-23
Est. Completion 2029-06-13
Phase NA

Sponsor

3Spine

2 total trials

What the Registry Record Tells You About NCT05438719

The ClinicalTrials.gov registry entry for NCT05438719 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 621-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (75% lower). The listed sponsor is 3Spine, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lumbar Spine Degeneration appearing as the primary indexed condition, and to 1 intervention - of which MOTUS Total Joint Replacement is the first listed.

NCT05438719 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, California.

Frequently Asked Questions

What is clinical trial NCT05438719 about?

NCT05438719 is a clinical study titled "MOTUS Total Joint Replacement Investigational Device Exemption Study". This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite en...

What is the current status of trial NCT05438719?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 158 participants. The study started on 2022-06-23. Estimated completion is 2029-06-13.

What conditions does trial NCT05438719 study?

This clinical trial studies the following conditions: Lumbar Spine Degeneration.

What interventions are being tested in trial NCT05438719?

The interventions under investigation include: MOTUS Total Joint Replacement (DEVICE).

Who is sponsoring clinical trial NCT05438719?

This trial is sponsored by 3Spine, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05438719 being conducted?

This trial has 14 study locations across California, Colorado, Florida, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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