Clinical trials: Fusion of Spine, Lumbar Region
Post-operative Pain
Dronabinol for Post-operative Pain After Lumbar Fusion
Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion
- Trial name
- NCT04346407
- Testing
- Dronabinol 2.5mg Cap
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Jeffrey L Gum MD
Spinal Stenosis
MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients…
- Trial name
- NCT04318795
- Testing
- minimally invasive spinal decompression (MIS-D), minimally invasive spinal decompression and fusion (MIS-TLIF)
- Volunteers
- 80 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Fusion of Spine, Lumbar Region
Trunk Forward Ability in Patients With Lumbar Fusion
The hypotheses of this study are as follows: 1. There is no significant muscle activity difference of each muscle in patients between pre and post operation. 2.
- Trial name
- NCT01585337
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- National Taiwan University Hospital
Lumbar Spondylosis, Fusion of Spine
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not.
- Trial name
- BRACE Pilot (NCT03439228)
- Testing
- Lumbar brace
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Hamilton Health Sciences Corporation
Degenerative Lumbar Spondylolisthesis
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05961956
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 5 people
- Sponsor
- Novadip Biosciences
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Kore Fiber PLF Study
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF).
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT07868510
- Testing
- Kore Fiber, Autologous bone graft
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Kolosis Bio, LLC
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Lumbar Spine Instability
MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
Degenerative disc disease (DDD) is the primary cause of low back pain. The most important factor in the development of DDD is the vertical load force on the disc, increasing the hydrostatic pressure and facilitating discs…
- Trial name
- NCT02815696
- Testing
- Magnetic Resonance Imaging
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Brugmann University Hospital
Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics
Intraoperative Bleeding in Lumbar Spine Surgery, Postoperative Pain in Lumbar Spine Surgery
Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery
This retrospective observational study evaluates the efficacy of periarticular vasoconstrictor infiltration (PVI) in reducing intraoperative bleeding and postoperative pain in adult patients undergoing lumbar fusion surgery at…
- Trial name
- NCT07530237
- Testing
- Periarticular Vasoconstrictor Infiltration
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spinal Fusion Acquired, Spinal Stenosis
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects.
- Conditions
- Spinal Fusion Acquired, Spinal Stenosis, Lesions of Lumbosacral Intervertebral Disc, Spinal Diseases
- Trial name
- DEXREDLOS (NCT00808665)
- Testing
- Dexmedetomidine, 0.9% Saline
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Vanderbilt University Medical Center
Degeneration Spine
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
- Trial name
- PSEUDOLUSE (NCT04308018)
- Testing
- S2alar-iliac screws, S1 screws
- Volunteers
- 148 people
- Sponsor
- Technical University of Munich
Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug)
Pain Control After Lumbar Spine Fusion
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion…
- Conditions
- Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug), Postoperative Pain
- Trial name
- NCT06484192
- Testing
- Naproxen 500 Mg, Ketorolac, OxyCODONE 5 mg Oral Tablet
- Where
- United States
- Volunteers
- 428 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
Low Back Disorder
MMG vs. EMG for Cortical Breach Detection
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring…
- Trial name
- NCT05352048
- Testing
- Triggered Electromyography, Mechanomyography
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Francis Farhadi
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion
NSAIDS Following Elective Lumbar Spine Fusion
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short…
- Conditions
- NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac, Postoperative Pain
- Trial name
- NCT07743606
- Testing
- Ketorolac, Naproxen, Standard Postoperative Pain Management
- Where
- United States
- Volunteers
- 428 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
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
LUMBAR STENOSIS, Sagittal Imbalance
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance).
- Conditions
- LUMBAR STENOSIS, Sagittal Imbalance, Degeneration Lumbar Spine, Lumbar Decompression
- Trial name
- NCT07139938
- Testing
- Isolated lumbar decomression
- Where
- 3 sites in Russia
- Volunteers
- 165 people
- Sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Spinal Fusion, Lumbar Discectomy
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.
- Trial name
- NCT00152152
- Testing
- Radiostereometric Analysis beads inserted during surgery
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- State University of New York - Upstate Medical University
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