Lumbar Degenerative Disc Disease Clinical Trial
Official title:
A Radiographic Analysis Using PureGen Osteoprogenitor Cell Allograft Versus Autologous Bone in Posterolateral Fusion in a Side-by-Side Comparison in the Same Patient (PLF)
NCT number | NCT01294007 |
Other study ID # | PRO-000061 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | November 2013 |
Verified date | September 2022 |
Source | Alphatec Spine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1 - Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF) - Unresponsive to conservative treatment for at least 6 months - Radiographic evidence of primary diagnosis Exclusion Criteria: - More than 2 levels requiring posterolateral fusion - Spondylolisthesis greater than Grade I - Prior failed fusion surgery at any lumbar level(s) - Systemic or local infection in the disc or cervical spine, past or present - Active systemic disease - Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing - Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified - BMI greater than 40 - Use of post operative Spinal Cord Stimulator (SCS) - Known or suspected history of alcohol and/or drug abuse - Involved in pending litigation or worker's compensation related to the spine - Pregnant or planning to become pregnant during the course of the study - Insulin-dependent diabetes mellitus - Life expectancy less than duration of study - Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires - Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs. - Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alphatec Spine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Fusion | Number of patients with fusion at the 6- and conditional 12- and 24-month visit | 6, 12 and 24 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01198470 -
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
|
N/A | |
Terminated |
NCT00744861 -
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
|
N/A | |
Completed |
NCT00949936 -
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
|
N/A | |
Completed |
NCT03974711 -
Rampart Duo Clinical (RaDical) Post-Market Study
|
||
Recruiting |
NCT01721889 -
Radiostereometric Analysis of Spine Arthrodesis
|
N/A | |
Terminated |
NCT02139527 -
CARES Lumbar Artificial Disc Registry
|
Phase 4 | |
Terminated |
NCT00878579 -
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
|
Phase 2 | |
Completed |
NCT01640977 -
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
|
N/A | |
Terminated |
NCT01689922 -
The Effectiveness of Anti-Gravity Treadmill Training
|
N/A | |
Enrolling by invitation |
NCT02529566 -
Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
|
N/A | |
Completed |
NCT02347410 -
Spineology Clinical Outcomes Trial: An IDE Investigation
|
N/A | |
Terminated |
NCT02070484 -
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
|
N/A | |
Terminated |
NCT01293981 -
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
|
N/A | |
Terminated |
NCT00640029 -
Evaluation of the Prosthetic Disc Replacement
|
N/A | |
Terminated |
NCT00456378 -
Study of the Safety and Effectiveness of DIAMâ„¢ Spinal Stabilization System Versus Conservative Care
|
N/A | |
Completed |
NCT03647501 -
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
|
N/A | |
Active, not recruiting |
NCT02297256 -
Prospective Study of Thoracolumbar Spinal Fusion Graft
|
N/A | |
Recruiting |
NCT05516992 -
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
|
Phase 3 | |
Completed |
NCT01323387 -
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
|
N/A |