NCT05438719

MOTUS Total Joint Replacement Investigational Device Exemption Study

An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: 3Spine · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multi-center (up to 20 investigational sites), prospective, non-blinded investigation of the MOTUS Total Joint Replacement (TJR) device. These data will be compared to a lumbar interbody fusion (transforaminal lumbar interbody fusion \[TLIF\] or posterior lumbar interbody fusion \[PLIF\]) control group enrolled in a separate real world evidence (RWE) study. Balance between groups will be achieved through sub classification using propensity scores by a blinded statistician.

Conditions

• Lumbar Spine Degeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-23
• Primary completion: 2026-06-13
• Completion: 2029-06-13
• First posted: 2022-06-30
• Last updated: 2025-12-03

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study