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MOTUS Total Joint Replacement Investigational Device Exemption Study

NCT05438719 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-22

No results posted yet for this 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

  • Lumbar Spine Degeneration

Interventions

DEVICE

MOTUS Total Joint Replacement

The MOTUS Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level.

Sponsors & Collaborators

  • 3Spine

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2026-02-09
Completion
2029-06-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438719 on ClinicalTrials.gov