Clinical trials: Lumbar Degenerative Diseases
Spinal Stenosis, Low Back Pain
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal.
- Conditions
- Spinal Stenosis, Low Back Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00418197
- Testing
- Total Facet Arthroplasty System® (TFAS®)
- Volunteers
- 450 people
- Sponsor
- Archus Orthopedics, Inc.
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Degenerative Disc Disease
INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal…
- Trial name
- NCT01491542
- Testing
- INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®, Autogenous Bone / CD HORIZON® Spinal System
- Volunteers
- 46 people
- Sponsor
- Medtronic Spinal and Biologics
Back Pain Lower Back Chronic, Lumbar Disc Degenerative Disease
Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization
This study investigates whether the effects of core muscle strengthening exercises on chronic low back pain and deep back muscle (multifidus) thickness differ in patients with different baseline muscle thicknesses.
- Trial name
- NCT06969508
- Testing
- core stabilitation exercises
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Medipol University
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Disc Disease, Lumbar Fusion
Lumbar Fusion With Nanotube Versus Titanium Cage
This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other.
- Trial name
- NCT07777718
- Testing
- Adaptix nanoPEEK Cage, Capstone PTC Cage
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Francis Farhadi
Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1
Evidence For Fusion In Spine With Orthoss®
This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
- Conditions
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
- Trial name
- EFFISO (NCT03853356)
- Testing
- Orthoss
- Where
- 3 sites in Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Geistlich Pharma AG
Pain, Stenosis
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft.
- Conditions
- Pain, Stenosis, Spondylolisthesis
- Trial name
- NCT00205101
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Lumbar Spinal Stenosis, Degenerative Lumbar Spinal Stenosis
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.
- Trial name
- ARCHIMEDE (NCT06335511)
- Testing
- microsurgical decompression, decompression and instrumented fusion
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Azienda Usl di Bologna
Hyperalgesia
Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation.
- Trial name
- ICALP (NCT00825422)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Bordeaux
Degenerative Lumbar Disease
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation
Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low.
- Trial name
- NCT01259960
- Where
- Austria
- Volunteers
- 187 people
- Sponsor
- Dr. Wolfgang Senker
Degenerative Lumbar Spinal Stenosis
Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back.
- Trial name
- BDYNCLIN (NCT04407338)
- Testing
- B-DYN, Conventional Bolted fusion (with or without cage)
- Where
- 2 sites in France
- Volunteers
- 216 people
- Sponsor
- Quanta Medical
Degenerative Disc Disease
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
- Trial name
- NCT00678171
- Testing
- TLIF with a PEEK Spacer System and XIA Spinal System
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Olympus Biotech Corporation
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Disc Disease
CHARITE™ vs. ALIF 5-Year Follow-up
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
- Trial name
- NCT00215332
- Testing
- CHARITE
- Where
- 10 sites in United States
- Volunteers
- 367 people
- Sponsor
- DePuy Spine
Spinal Stenosis, Spondylolisthesis
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format.
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- RAMP (NCT01716182)
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
Lumbar Osteoarthritis
Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
The study has before mentioned the concept of "knee - spine syndrome" domestically, on the basement of which, the new study intends to perform another further study on the relationship between lumbar and lower extremity…
- Trial name
- NCT03364790
- Testing
- PLIF, TKA
- Volunteers
- 120 people
- Sponsor
- Peking University People's Hospital
Sciatica, Spinal Stenosis of Lumbar Region
Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long-term results of prolotherapy are more effective than those of the current conventional treatment: epidural steroid injections (ESI).
- Conditions
- Sciatica, Spinal Stenosis of Lumbar Region, Degeneration of Lumbar or Lumbosacral Intervertebral Disc
- Trial name
- NCT01934868
- Testing
- prolotherapy solution of 20% dextrose, Epidural Steroid Injection
- Where
- Israel
- Volunteers
- 110 people
- Sponsor
- Hadassah Medical Organization
Disc Herniation
Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that…
- Trial name
- UBEVAL (NCT06448416)
- Testing
- UBE
- Where
- France
- Volunteers
- 500 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche