Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)

Status Completed

Clinical Trial Summary

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells attached to the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 20,000 cases worldwide.

Clinical Trial Description

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive PLIF surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their PLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and BMP. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00941980
Study type	Observational
Source	NuVasive
Contact
Status	Completed
Phase	N/A
Start date	June 2009
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting	`NCT05114135` - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)	N/A
Suspended	`NCT04735185` - Stem Cells vs. Steroids for Discogenic Back Pain	N/A
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Completed	`NCT04057235` - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting	`NCT02969616` - Trinity Elite in Lumbar Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02104167` - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed	`NCT00965380` - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Completed	`NCT00758719` - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed	`NCT00165893` - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease	Phase 4
Terminated	`NCT01494493` - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease	N/A
Recruiting	`NCT04727385` - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease	N/A
Completed	`NCT04849429` - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain	Phase 1
Recruiting	`NCT04469387` - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion	N/A
Recruiting	`NCT04056520` - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed	`NCT04119466` - Stabilizing Training in Degenerative Disc Disease	N/A