Clinical trials: Lumbar Degenerative Diseases
Spinal Fusion, Spinal Stenosis
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome.
- Conditions
- Spinal Fusion, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT03883022
- Testing
- with U-VANCO (vancomycin hydrochloride), without U-VANCO (vancomycin hydrochloride)
- Where
- Taiwan
- Volunteers
- 400 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
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
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
- Trial name
- NCT03928041
- Testing
- Device: EVOS Lumbar Interbody System (EVOS-HA)
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Invibio Ltd
Degenerative Spine Disease, Spinal Stenosis Lumbar
VR-Cognitive Behavioral Therapy Prehabilitation for Spinal Deformity Surgery
The goal of this clinical trial is to learn whether a virtual reality-based cognitive behavioral therapy (VR-CBT) prehabilitation program can improve recovery and quality of life for adults undergoing elective spine surgery.
- Trial name
- VR-CBT (NCT07777679)
- Testing
- Virtual Reality-Based CBT Prehabilitation (VR-CBT), CBT Prehabilitation without Virtual Reality
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of California, Irvine
Lumbar Degenerative Disease, Lumbar Degenerative Disc Disease
ISOVUE Comparative Trial
This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.
- Conditions
- Lumbar Degenerative Disease, Lumbar Degenerative Disc Disease, Degenerative Spine
- Trial name
- ISOVUE (NCT07363759)
- Testing
- ISOVUE 300 Observation, ISOVUE 300 Feedback
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
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
Chronic Back Pain, Degenerative Disc Disease Lumbar
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
- Trial name
- ADAPT (NCT07137559)
- Testing
- CELZ-201-DDT
- Sponsor
- Creative Medical Technology Holdings Inc
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive
Pain, Postoperative, Lumbar Spine Degeneration
Epidural PCA on Pain Relief After L-spine Surgery
This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries.
- Conditions
- Pain, Postoperative, Lumbar Spine Degeneration, Analgesia, Patient-Controlled, Epidural Anesthesia
- Trial name
- NCT06316921
- Testing
- Epidural patient-controlled analgesia, Standard postoperative pain management
- Where
- Taiwan
- Volunteers
- 209 people
- Sponsor
- Taipei City Hospital
Lumbar Spondylosis, Lumbar Spondylolisthesis
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
The purpose of this study is to determine the effects of 12 weeks of daily treatment with teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral spine fusion surgery for degenerative…
- Conditions
- Lumbar Spondylosis, Lumbar Spondylolisthesis, Adult Degenerative Lumbar Scoliosis
- Trial name
- NCT01292252
- Testing
- teriparatide
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Shane Burch
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Paraspinal Muscles, Degenerative Lumbar Diseases
The Impact of Paraspinal Muscle Atrophy in Spine Surgeries
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases.
- Trial name
- NCT07002918
- Where
- Egypt
- Volunteers
- 55 people
- Sponsor
- Assiut University
Spinal Degenerative Disorder, Spinal Stenosis
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery.
- Conditions
- Spinal Degenerative Disorder, Spinal Stenosis, Spondylosis
- Trial name
- PASS (NCT04591249)
- Testing
- Physical activity intervention, Usual care
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Vanderbilt University Medical Center
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
Early Lumbar Disc Degeneration
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
- Trial name
- NCT01158924
- Testing
- Intradiscal rhGDF-5
- Where
- 3 sites in Australia
- Volunteers
- 40 people
- Sponsor
- DePuy Spine
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
Degenerative Disc Disease
AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain
- Trial name
- NCT03263611
- Testing
- AMG0103
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- AnGes, Inc.
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
Lower Back Pain of Disc Origin, Joint Facet Syndrome
Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including…
- Conditions
- Lower Back Pain of Disc Origin, Joint Facet Syndrome, Lumbar Canal Stenosis, Spinal Disease
- Trial name
- IntraLT (NCT07790328)
- Testing
- IntraSPINE
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Cousin Biotech
Degenerative Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.