Clinical trials: Spinal Surgery
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Idiopathic Scoliosis
Scoliosis Surgery Using the PASS® LP System
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the…
- Trial name
- NCT01019109
- Testing
- Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
- Where
- 3 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medicrea, USA Corp.
Failed Back Surgery Syndrome
Spinal Cord Stimulation Frequency Study
The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).
- Trial name
- NCT01750229
- Testing
- 1200 Hz, 3030 Hz, 5882 Hz
- Where
- United Kingdom
- Volunteers
- 53 people
- Sponsor
- MedtronicNeuro
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics
Pain
Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
- Trial name
- NCT01983111
- Testing
- buprenorphine, tramadol/acetaminophen
- Where
- South Korea
- Volunteers
- 136 people
- Sponsor
- Mundipharma Korea Ltd
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Kyphosis, Spinal Fractures
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
- Trial name
- LOADPRO (NCT02768675)
- Testing
- LOADPRO
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intellirod Spine
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Spine Fusion, Spinal Deformity
Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of…
- Trial name
- NCT05001893
- Testing
- S53P4 bioactive glass putty
- Where
- Finland
- Volunteers
- 500 people
- Sponsor
- Bonalive Biomaterials Ltd
Intraoperative Monitoring, Spinal Diseases
Intraoperative Monitoring (IOM) Patient Registry
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the…
- Trial name
- IOM (NCT02187653)
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- DC2 Healthcare
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798239
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc
Lumbar Disc Herniation Surgery, Disc Herniation
Return to Activity After Surgery for Lumbar Disc Herniation
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
- Trial name
- NCT07667348
- Testing
- Postoperative therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Intrinsic Therapeutics
Failed Back Surgery Syndrome
Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain
Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain. Various clinical studies have shown a beneficial effect of SCS on pain in patients with Failed Back Surgery Syndrome (FBSS).
- Trial name
- NCT01096147
- Testing
- Spinal cord stimulation with eight polar electrode
- Where
- 8 sites in Belgium, Norway and 1 more
- Volunteers
- 80 people
- Sponsor
- Rik Buschman, PhD
Spinal Tumor, Spinal Injury
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery.
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis
- Trial name
- NCT07354178
- Testing
- CollaStat®, Floseal®
- Where
- 3 sites in South Korea
- Volunteers
- 130 people
- Sponsor
- DALIM TISSEN Co., Ltd.
Femoral Fracture, Tibial Fracture
The Development of a Surgical Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT01300520
- Testing
- Target Tape
- Where
- Canada
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Aeos Biomedical Inc.
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
INDUCE: A Prospective 2-Year Spine Registry
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine.
- Trial name
- NCT06971835
- Testing
- NMP
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Red Rock Regeneration Inc.
Spinal Stenosis, Lumbar Region With Neurogenic Claudication
Assessing Superion Clinical Endpoints vs. Decompression
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct…
- Trial name
- ASCEND (NCT03048955)
- Testing
- Superion® IDS, Direct decompression Surgery
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VertiFlex, Incorporated
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Chronic Pain
Algovita Spinal Cord Stimulation System Hi-Fi Study
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high…
- Trial name
- NCT03622866
- Testing
- Ultra-high pulse width stimulation, Traditional pulse width stimulation
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- Nuvectra