Clinical Trials Logo
  1. Home
  2. Degenerative Disc Disease
  3. NCT00736398
  4. Details
NCT00736398 Clinical Trial

Fusion Assessment Clinical Trial

Degenerative Disc Disease Clinical Trial

— FACT  

Official title:
Fusion Assessment Clinical Trial (FACT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00736398
Other study ID # 01000-T02
Secondary ID
Status Completed
Phase N/A
First received August 14, 2008
Last updated April 1, 2013
Start date August 2008

Study information
Verified date April 2013
Source Flexuspine, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility Inclusion Criteria:

- Lumbar DDD

- Candidate for spinal fusion

- Provide written informed consent

Exclusion Criteria:

- Prior lumbar spinal fusion

- Metabolic bone disease

- Morbid obesity

- Systemic infection or active malignancy

- Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Spinal fusion
Spinal fusion

Locations
Country Name City State
United States Greater Baltimore Medica Center Baltimore Maryland
United States MUSC Charleston South Carolina
United States Florida Spine Institute Clearwater Florida
United States Foundation for Orthopaedic Research and Education Temple Terrace Florida
United States Guy Danielson, M.D. Tyler Texas
United States The Washington Hospital Washington Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Flexuspine, Inc.

Country where clinical trial is conducted

United States, 

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)
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
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