Clinical trials: Lumbar Spine Degenerative Changes
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
Lumbar Degenerative Disc Disease, Spinal Stenosis
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- NCT02070484
- Testing
- NuCel, Demineralized Bone Matrix
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- OhioHealth
Spinal Stenosis Lumbar
Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series
Lumbar spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the lumbar spine.
- Trial name
- MELD-1 (NCT07045714)
- Testing
- Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD)
- Where
- Mexico
- Volunteers
- 78 people
- Sponsor
- TecSalud Investigación Clínica
Degenerative Lumbar Spine Diseases
Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion
This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the…
- Trial name
- AgeTLIF (NCT05266638)
- Testing
- Data collection (radiological parameters, outcome information) from electronic patient files in hospital data system
- Where
- Switzerland
- Volunteers
- 170 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Lumbar Degenerative Disease
CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System in Lumbar Degenerative Disease
This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people.
- Trial name
- NCT06940453
- Testing
- CONDUIT
- Where
- Ireland
- Volunteers
- 35 people
- Sponsor
- University College Dublin
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
This multicenter randomized controlled trial will evaluate whether an additional preoperative study visit using the Dialogue Support (DS) tool improves patient information, expectations, and outcomes among adults scheduled for…
- Conditions
- Spinal Stenosis Lumbar, Disc Herniation, Lumbar, Degenrative Disc Disease
- Trial name
- MORESP (NCT07788872)
- Testing
- Dialogue Support Study Visit
- Where
- 2 sites in Norway
- Volunteers
- 440 people
- Sponsor
- University Hospital, Akershus
Lumbar Degenerative Disc Disease, Cervical Degenerative Disc Disease
Evaluation of the Prosthetic Disc Replacement
Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for the patients when nonsurgical management has…
- Conditions
- Lumbar Degenerative Disc Disease, Cervical Degenerative Disc Disease, Kyphosis
- Trial name
- EVA (NCT00640029)
- Testing
- Arthrodesis, Arthroplasty (PRODISC-C® , PRODISC-L®, Mobi-C®, Mobidisc®, PrestigeLP®, A-Mav®, O-Mav®, DISCOCERV®)
- Where
- 2 sites in France
- Volunteers
- 301 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lumbar Disc Herniation, Degenerative Spinal Stenosis
CETIS-I (CEra Traction Improves Spine-I)
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and…
- Conditions
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- Trial name
- NCT05549596
- Testing
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Ceragem Clinical Inc.
Decompression, Surgical
A Study on the Use of Educational Programs Prior to Lumbar Spinal Surgery
This study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve…
- Trial name
- NCT00719485
- Testing
- Educational program
- Volunteers
- 70 people
- Sponsor
- Sunnybrook Health Sciences Centre
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 people
- Sponsor
- LDR Spine USA
Back Pain, Radiculopathy Lumbar
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery.
- Conditions
- Back Pain, Radiculopathy Lumbar, Degenerative Lumbar Spinal Stenosis
- Trial name
- NCT03801356
- Testing
- Selective Nerve Root Block
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
Degenerative Disc Disease, Spondylolisthesis
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Trial name
- NCT04416321
- Testing
- Surgery with the Keos Lumbar Interbody Fusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Invibio Ltd
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.
Spondylolisthesis, Scoliosis
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Trial name
- NCT02225444
- Testing
- OsteoAMP
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Bioventus LLC
Lumbar Spondylolisthesis Involving L4-L5, and/or, Degenerative Discopathy Involving L4-L5
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in…
- Trial name
- NCT01552707
- Testing
- XCEL-MT-OSTEO-ALPHA, Standard treatment
- Where
- 5 sites in Spain
- Volunteers
- 69 people
- Sponsor
- Banc de Sang i Teixits
Lumbar Spine Degeneration
Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness, and there is no scale for evaluating lumbar stiffness in China.Based on the Delphi method and the analytic hierarchy process, this study will…
- Trial name
- DPROIPLDDALF (NCT04781517)
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Peking University Third Hospital
Disc Degenerative Disease, Spine Fusion for Degenerative Spine Disease
Comparison of Posterior Cellular Bonegraft Options for Single Level Lumbar Spinal Fusion
This study involves the assessment of alternatives to iliac bone graft during spinal fusion surgery. Four types of bone graft alternatives are being compared to iliac bone graft during the posterior portion of an…
- Trial name
- NCT07187362
- Testing
- Use iliac bone graft, use bone morphogenetic protein, use bone derived allograft MSCs
- Volunteers
- 119 people
- Sponsor
- Midwest Spine & Brain Institute
Degenerative Lumbar Spinal Stenosis
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis
- Trial name
- NCT03302507
- Testing
- BESS, ULBD
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- Seoul National University Hospital