Clinical trials: Degenerative Spine Diseases
Intervertebral Disc Degeneration, Spinal Fusion
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
- Trial name
- NCT03908203
- Testing
- Minimally invasive one-level lumbar deformity correction
- Where
- Russia
- Sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
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 Spondylolisthesis, Pseudoarthrosis
Dynesys Spinal System Post Market 522 Study
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
- Trial name
- NCT01528072
- Testing
- Dynesys Spinal System
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Lumbar Degenerative Disc Disease
Spineology Clinical Outcomes Trial: An IDE Investigation
This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.
- Trial name
- SCOUT (NCT02347410)
- Testing
- SIFS graft containment device
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Spineology, Inc
Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1.
- Conditions
- Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT01097486
- Testing
- NeoFuse, Allograft
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
Intervertebral Disc Degeneration
EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
This is an open-label, single-center Phase I/II clinical trial investigating the safety and efficacy of autologous nucleus pulposus cells (aNPC) in patients with disc degeneration.
- Trial name
- NCT07168603
- Testing
- aNPC
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- ASTEROGENE Biomedical Co. Ltd.
Chronic Low Back Pain, Degenerative Disc Disease
Stem Cells vs. Steroids for Discogenic Back Pain
This is a randomized, comparative-effectiveness study comparing intradiscal autologous stem cells (from bone marrow aspirate) to intradiscal corticosteroid for the treatment of chronic discogenic low back pain (LBP).
- Trial name
- NCT04735185
- Testing
- Autologous stem cells, Corticosteroid, Local anesthetic
- Where
- United States
- Sponsor
- Johns Hopkins University
Lumbar Spine Degeneration, Lumbar Spinal Stenosis
LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis
Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery.
- Trial name
- NCT04094220
- Testing
- Lateral lumbar interbody fusion
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Spinal Stenosis
The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis
The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS).
- Trial name
- IVANOS (NCT01618435)
- Testing
- i-FACTOR
- Where
- 2 sites in Denmark
- Volunteers
- 108 people
- Sponsor
- Sygehus Lillebaelt
Cervical Radiculopathy, Degenerative Disc Disease
Restore CLINICAL TRIAL
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the…
- Trial name
- NCT01609374
- Testing
- M6-C Artificial Cervical Disc, Anterior plate system with corticocancellous allograft bone
- Volunteers
- 258 people
- Sponsor
- Spinal Kinetics
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
Degenerative Spondylolisthesis
Multimodal Perioperative Pain Management
Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery.
- Trial name
- NCT01513564
- Testing
- Postoperative epidural morphine, Local anaesthesia
- Where
- Denmark
- Volunteers
- 120 people
- Sponsor
- Northern Orthopaedic Division, Denmark
Degenerative Disc Disease, Spinal Stenosis
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01829997
- Testing
- nanOss Bioactive 3D BVF
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pioneer Surgical Technology, Inc.
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
Degenerative Lumbar Spine Diseases
Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases
This study will combine virtual reality (VR) technology with machine learning to focus on functional movement. Patients' symptoms will be evaluated, and exercise instruction with real-time feedback will be provided.
- Trial name
- NCT05425680
- Testing
- Core muscle training
- Where
- 2 sites in Taiwan
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Degeneration of Lumbar Intervertebral Disc
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in…
- Trial name
- NCT01491373
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autograft/LT-CAGE® Device
- Volunteers
- 14 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Degenerative Disease
The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics.
- Trial name
- NCT06075966
- Testing
- Non-fusion group, Fusion group
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Qianfoshan Hospital