Clinical trials: Degenerative Lumbar Diseases
Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band…
- Trial name
- NCT03115983
- Testing
- LimiFlex, Fusion Instrumentation, Decompression
- Where
- 28 sites in United States
- Volunteers
- 299 people
- Sponsor
- Empirical Spine, Inc.
Paraspinal Muscles, Low Back Pain
Multimodal Exercise Therapy for Non-Surgical Intervention of Nonspecific Low Back Pain.
This multicenter, assessor-blinded, two-arm parallel randomized controlled trial (N = 314) will compare the efficacy and safety of a 6-week multidimensional exercise program plus usual pharmacological care (experimental arm)…
- Conditions
- Paraspinal Muscles, Low Back Pain, Machine Learning, Radiomics
- Trial name
- METNLBP (NCT07353372)
- Testing
- Multidimensional exercise intervention, Oral NSAIDs
- Where
- China
- Volunteers
- 314 people
- Sponsor
- Xuanwu Hospital, Beijing
Lumbar Spinal Stenosis
Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower…
- Trial name
- NCT01057641
- Testing
- Spacer, physiotherapy
- Where
- 2 sites in Germany
- Volunteers
- 22 people
- Sponsor
- University of Cologne
Degenerative Disc Disease
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure.
- Trial name
- NCT00947583
- Testing
- Osteocel Plus
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NuVasive
Lumbar Degenerative Disc Disease
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10…
- Trial name
- NCT01640977
- Testing
- Open PLIF (posterior lumbar interbody fusion), MAS PLIF
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- NuVasive
Lumbar Spondylolisthesis
Retrospective Image Analysis of Degenerative Lumbar Disease Patients
The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited.
- Trial name
- NCT04886557
- Testing
- L4-L5 decompression and dynamic instrumentation
- Where
- Taiwan
- Volunteers
- 139 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Degenerative Disc Disease
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients…
- Trial name
- NCT01494441
- Testing
- rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System, Autograft/TSRH® Spinal System
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
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 Spinal Stenosis, Intervertebral Disc Degeneration
Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis
The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative…
- Trial name
- NCT04594980
- Testing
- lumbar fusion
- Where
- Russia
- Volunteers
- 96 people
- Sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Degenerative Disc Disease, Degenerative Spondylolisthesis
XLIF Decade Plate System Study
The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04689880
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- NuVasive
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
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease.
- Trial name
- NCT06144970
- Testing
- TG-C High Dose, TG-C Mid Dose, TG-C Low Dose
- Volunteers
- 24 people
- Sponsor
- Kolon TissueGene, Inc.
Spondylolisthesis Degenerative, Spinal Fusion
The Effect of Lordosis on Clinical Outcome After Spinal Fusion for One-level Degenerative Spondylolysthesis
Degenerative spondylolisthesis is a common spinal degenerative disease. It is defined as the slippage of one vertebrae on the vertebrae bellow.
- Trial name
- NCT04174144
- Testing
- Single-level TLIF
- Where
- Slovenia
- Volunteers
- 32 people
- Sponsor
- University Medical Centre Ljubljana
Degenerative Disc Disease, Facet Joint Syndrome
Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome
Autologous Platelet-Rich-Plasma (PRP) represents a regenerative therapy that has gained remarkable ground in the field of orthopaedics in recent years.
- Trial name
- NCT04816747
- Testing
- Autologous PRP
- Volunteers
- 50 people
- Sponsor
- Stylianos Kapetanakis
Degenerative Disc Disease (DDD)
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
- Trial name
- HYDRAFIL-D (NCT06011551)
- Testing
- The ReGelTec HYDRAFIL™ System, Conservative Care Management
- Where
- 16 sites in United States, Canada
- Volunteers
- 225 people
- Sponsor
- ReGelTec, Inc.
Spine Degeneration, Lumbar Degenerative Disease
Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II
This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be…
- Conditions
- Spine Degeneration, Lumbar Degenerative Disease, Frail Elderly, Enhanced Recovery After Surgery (ERAS) Protocol
- Trial name
- PRACTICE-2 (NCT07396077)
- Testing
- Multimodal physiological reserve optimizing prehabilitation program, Usual Care
- Where
- 4 sites in China
- Volunteers
- 248 people
- Sponsor
- Xuanwu Hospital, Beijing
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
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TS Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery.
- Trial name
- NCT07834736
- Testing
- Posterior lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
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
Spinal Injuries
Response Shift in Patient Expectations and Functional Outcome
The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome.
- Trial name
- NCT00289393
- Testing
- Perceived outcome by both patient and physician
- Where
- Canada
- Sponsor
- Sunnybrook Health Sciences Centre