Clinical trials: Degenerative Spine Diseases
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy
- Trial name
- NCT06320899
- Testing
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Where
- 2 sites in Switzerland
- Volunteers
- 126 people
- Sponsor
- SpineSave AG
Lumbar Disc Degeneration, Lumbar Disc Disease
Total Lumbar Disc Prosthesis and Subsequent Work Activity at at Least Five Years After Total Lumbar Disc Replacement
Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis.
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Disease, Sciatica, Lumbar Disc Herniation
- Trial name
- NCT06989632
- Testing
- Total lumbar disc prosthesis (Baguera®L, Spineart, Switzerland)
- Where
- Spain
- Volunteers
- 130 people
- Sponsor
- University of Valencia
Degenerative Disc Disease
A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion
The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.
- Trial name
- NCT06115512
- Testing
- AGA111
- Where
- 35 sites in China
- Volunteers
- 412 people
- Sponsor
- Angitia Biopharmaceuticals
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Degenerative Disc Disease
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
- Trial name
- VAST (NCT03709901)
- Testing
- Active Allograft
- Where
- 13 sites in United States
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- VIVEX Biologics, Inc.
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Spine Injuries and Disorders
Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union…
- Trial name
- NCT06736106
- Testing
- screening
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Istituto Ortopedico Rizzoli
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Degenerative Disc Disease, Degenerative Spondylolisthesis
Fibergraft Interbody Fusion Retrospective
A single center study of clinical and radiological outcomes in a retrospective cohort of patients treated with Lumbar Interbody Fusion augmented with Prosidyan Fibergraft for 1 or 2 level degenerative spinal disease by a single…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Degeneration, Spinal Stenosis
- Trial name
- FIFR (NCT03898232)
- Testing
- Computed Tomography (CT) Scan of the Lumbar Spine
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Bone and Joint Clinic of Baton Rouge
Degenerative Spine Diseases
A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）
Study type: The objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted…
- Trial name
- DSDC (NCT05867732)
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Xiamen University
Lumbar Spine Instability, Lumbar Spinal Stenosis
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery.
- Conditions
- Lumbar Spine Instability, Lumbar Spinal Stenosis, Lumbar Spine Degeneration
- Trial name
- NCT05630404
- Testing
- Surgical ESPB, US guided ESPB
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Bursa City Hospital
Lumbar Degenerative Disc Disease
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels…
- Trial name
- NCT00878579
- Testing
- PDS System, Fusion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Interventional Spine, Inc.
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Spinal Stenosis Lumbar
Coflex PS3 Actual Conditions for Use Study
A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA…
- Trial name
- PAS003 (NCT02555280)
- Testing
- coflex® Interlaminar Technology, Decompression
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Companion Spine, LLC
Intervertebral Disc Displacement, Spinal Stenosis Lumbar
Artificial Intelligence Enabled Decision Support for Selection of Patients for Lumbar Spine Surgery
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement.
- Conditions
- Intervertebral Disc Displacement, Spinal Stenosis Lumbar, Lumbar Disc Herniation, Lumbar Spine Degeneration
- Trial name
- NCT06806969
- Testing
- Decision support
- Where
- Norway
- Volunteers
- 26 people
- Sponsor
- University Hospital of North Norway
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Spine Degeneration, Spine Disorder
Rate of Bone Union After Surgery With Stand-alone Fibergraft
Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking.
- Conditions
- Spine Degeneration, Spine Disorder, Spine Pain, Spine Fusion
- Trial name
- Fibergraft (NCT07199075)
- Testing
- Questionnaires, Computer Tomography
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- AO Innovation Translation Center
Lumbar Disc Disease, Lumbar Spine Degeneration
The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)
The primary objective is to determine the validity of the Six-Minute-Walking Test (6WT) and Timed-Up and Go (TUG) test to measure objective functional impairment (OFI) in patients undergoing either interlaminar epidural steroid…
- Conditions
- Lumbar Disc Disease, Lumbar Spine Degeneration, Lumbar Spinal Stenosis
- Trial name
- NCT04062942
- Where
- 2 sites in Switzerland
- Volunteers
- 50 people
- Sponsor
- Cantonal Hospital of St. Gallen
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
Low Back Pain
Wallis Mechanical Normalization System for Low Back Pain
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
- Trial name
- NCT00134537
- Testing
- Interspinous process and dynamic stabilization, Conservative Care
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer Spine