MOTUS Total Joint Replacement Investigational Device Exemption Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Lumbar Spine Degeneration

Clinical Trial Details

NCT number	NCT05438719
Study type	Interventional
Source	3Spine
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 20, 2022
Completion date	June 20, 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04140344` - The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions	N/A
Completed	`NCT04914728` - Mini-invasive Lumbar Arthrodesis in Ambulatory	N/A
Recruiting	`NCT05527145` - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial	N/A
Completed	`NCT05630404` - Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block	N/A
Recruiting	`NCT05452694` - OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
Recruiting	`NCT04823858` - 3Spine Lumbar Fusion Real World Evidence Study
Recruiting	`NCT06154005` - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion	Phase 1/Phase 2
Recruiting	`NCT04781517` - Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
Completed	`NCT03977961` - The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Completed	`NCT03176303` - Study Using the SpinalStim Device Following Lumbar Fusion Surgery
Recruiting	`NCT06462729` - LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)	Phase 1/Phase 2
Completed	`NCT01143324` - A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Not yet recruiting	`NCT05388383` - Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
Completed	`NCT06316921` - Epidural PCA on Pain Relief After L-spine Surgery
Completed	`NCT03452449` - Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery
Terminated	`NCT03527966` - rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures	Phase 4
Withdrawn	`NCT05408923` - Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery	Phase 4
Terminated	`NCT01415908` - INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine	Phase 3
Completed	`NCT04062942` - The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)
Completed	`NCT03088306` - Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients	Early Phase 1