Clinical trials: Lumbar Spine Degeneration
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
Spinal Stenosis, Spinal Stenosis Lumbar
Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs.
- Conditions
- Spinal Stenosis, Spinal Stenosis Lumbar, Degeneration Lumbar Spine, Degeneration Spine
- Trial name
- UppSten (NCT03495661)
- Testing
- Decompression
- Where
- Sweden
- Volunteers
- 156 people
- Sponsor
- Uppsala University
Spondylolisthesis
Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Lumbar-spine Fusion
This study is designed as a randomized, parallel-group, therapy-controlled trial in a clinical care setting at a university hospital.
- Trial name
- D-Rod (NCT01852526)
- Testing
- Experimental: hybrid system, Active Comparator: Plif
- Where
- 2 sites in Germany
- Volunteers
- 5 people
- Sponsor
- University of Cologne
Lumbar Spondylolisthesis, Lumbar Spine Degeneration
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
To identify the current mortality rate for initial Anterior Lumbar Interbody Fusion(ALIF)procedures. Establish/prove mortality rates for this operation have dropped in the past decade.
- Trial name
- NCT05945550
- Where
- United States
- Volunteers
- 3,500 people
- Sponsor
- Methodist Health System
Discogenic Pain, Platelet-rich Plasma
Platelet-rich Plasma for Low Back Pain
This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous PRP.
- Trial name
- NCT03197415
- Testing
- Platelet-rich plasma
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Pei-Yuan Lee, MD
Spinal Fusion
Bone Marrow Clot for Posterior Lumbar Fusion
Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion.
- Trial name
- NCT05936047
- Testing
- Vertebral bone marrow clot
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Istituto Ortopedico Rizzoli
Degenerative Lumbar Disease
Decision Making in Degenerative Lumbar Spine : CT vs. MRI
To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.
- Trial name
- NCT04130035
- Volunteers
- 30 people
- Sponsor
- Assiut University
Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
A Pivotal Study of the Premia Spine TOPS™ System
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following…
- Trial name
- NCT03012776
- Testing
- Total Posterior Spine System (TOPS), Transforaminal Lumbar Interbody Fusion (TLIF)
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Premia Spine
Low Back Pain, Degeneration of Lumbosacral Intervertebral Disc
The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
The purpose of this study is to compare changes in spinal stiffness and back muscle activity between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic participants.
- Conditions
- Low Back Pain, Degeneration of Lumbosacral Intervertebral Disc, Muscle Weakness, Spine Stiffness
- Trial name
- NCT01761838
- Testing
- SMT for low back pain patients, Pain induction (optional), Low back pain participants without SMT
- Where
- Canada
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Lumbar Spine Degeneration
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
- Trial name
- NCT03527966
- Testing
- 5cc Vivigen and local autograft, Small kit rhBMP-2 with local autograft
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Lumbar Spine Instability, Lumbar Spinal Stenosis
Modified-Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block Following Lumbar Instrumentation Surgery
Ultrasound (US)-guided peripheral nerve blocks have been used increasily due to the advantages of ultrasound in anesthesia practice. TLIP block is one of these nerve blocks performed under US guidance.
- Conditions
- Lumbar Spine Instability, Lumbar Spinal Stenosis, Lumbar Disc Disease, Lumbar Spine Degeneration
- Trial name
- NCT04189341
- Testing
- Erector spinae plane block (Group E), Modified-thoracolumbar interfascial plane block
- Where
- Turkey (Türkiye)
- Sponsor
- Medipol University
Constriction, Pathologic, Spine Degeneration
Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction…
- Conditions
- Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy
- Trial name
- NCT05817747
- Testing
- Dialogue support tool
- Where
- 10 sites in Sweden
- Volunteers
- 900 people
- Sponsor
- Sahlgrenska University Hospital
Lumbar Degenerative Disc Disease
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease.
- Trial name
- MODEL (NCT05516992)
- Testing
- SB-01 For Injection
- Where
- 30 sites in United States
- Volunteers
- 417 people
- Sponsor
- Spine BioPharma, Inc
Spine Degeneration
Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis
This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar…
- Trial name
- RFPMDLS (NCT06797700)
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- The First People's Hospital of Yunnan
Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis
A Study on the Clinical Use of a New Expandable OLIF Cage With Posterior Bone Grafting in Lumbar Spine Surgery
This clinical trial aims to evaluate the safety and effectiveness of a novel expandable OLIF (Oblique Lateral Interbody Fusion) cage with posterior bone grafting in patients with lumbar degenerative diseases.
- Conditions
- Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis, Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Trial name
- NCT07028099
- Testing
- Expandable OLIF cage with posterior bone grafting, Conventional OLIF cage
- Volunteers
- 340 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Degenerative Disease of the Lumbosacral Spine
Transforaminal Lumbar Interbody Fusion (TLIF)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be…
- Trial name
- TLIF (NCT04073563)
- Testing
- Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems
- Where
- 46 sites in United States, China
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed.
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degeneration Spine
- Trial name
- NCT04469387
- Testing
- Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis, Responsible segments fused
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking University Third Hospital
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease, Discogenic Low Back Pain
A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine
TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility.
- Trial name
- NCT03716947
- Testing
- Device: ZACK, Device: ORBIT, Device: SASCA
- Where
- Sweden
- Volunteers
- 246 people
- Sponsor
- Karolinska Institutet
Discogenic Low Back Pain, Intervertebral Disc Degeneration
RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain
he RenewDisc Trial is a prospective observational clinical study evaluating outcomes in patients with confirmed discogenic low back pain who undergo standard clinical care using endoscopic spine procedures.
- Conditions
- Discogenic Low Back Pain, Intervertebral Disc Degeneration, Lumbar Disc Disease, Chronic Low Back Pain
- Trial name
- RENEWDISC (NCT07338877)
- Where
- Slovakia
- Volunteers
- 120 people
- Sponsor
- EPC Education s.r.o.