Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active NA study of Lumbar Spine Degeneration, sponsored by 3Spine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.
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
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2029-06-13 |
| Phase | NA |
What the registry record for NCT05438719 still lists
NCT05438719 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 621-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (75% lower).
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 lists 14 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Lumbar Spine Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
RECRUITING · NA
-
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
RECRUITING · Phase 1
-
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
RECRUITING · Phase 4
-
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
RECRUITING
-
3Spine Lumbar Fusion Real World Evidence Study
ACTIVE NOT RECRUITING
-
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04486833 · 158 participants · Phase 1
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
- NCT04697966 · 158 participants · NA
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
- NCT04969835 · 158 participants · Phase 1
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
- NCT05230732 · 158 participants · NA
Neuromodulation of Inflammation and Endothelial Function
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI