Clinical trials: Back Surgery
Surgery
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
- Trial name
- NCT01559506
- Testing
- Air Barrier System device
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Nimbic Systems, LLC
Diabetic Macular Edema
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
- Trial name
- MIVI-II (NCT00412451)
- Testing
- ocriplasmin
- Where
- 15 sites in Belgium, Germany and 4 more
- Volunteers
- 51 people
- Sponsor
- ThromboGenics
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
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
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Chronic Pain
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal…
- Trial name
- SOLIS (NCT04676022)
- Testing
- WaveWriter, Conventional Medical Managament
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Boston Scientific Corporation
Spinal Injuries, Adhesions
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group…
- Trial name
- NCT00387829
- Testing
- DuraGen Plus Adhesion Barrier Matrix
- Where
- 36 sites in United States
- Volunteers
- 347 people
- Sponsor
- Integra LifeSciences Corporation
Vitreomacular Traction
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
- Trial name
- NCT00435539
- Testing
- ocriplasmin
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 60 people
- Sponsor
- ThromboGenics
Glaucoma
5 Years Long Term Results After Standalone CyPass-Implantation
This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure.
- Trial name
- NCT03114059
- Testing
- Glaucoma diagnostics
- Where
- Germany
- Volunteers
- 230 people
- Sponsor
- Dietrich-Bonhoeffer-Klinikum
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
Partial Edentulism
Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
- Trial name
- NCT00782171
- Testing
- SLActive dental implant
- Where
- 19 sites in United States, Austria and 7 more
- Volunteers
- 266 people
- Sponsor
- Institut Straumann AG
Cataract, Astigmatism
Toric Intraocular Lens Following Cataract Surgery
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a…
- Trial name
- NCT01140477
- Testing
- Toric Accommodating Lens, Accommodating Lens
- Where
- United States
- Volunteers
- 229 people
- Sponsor
- Bausch & Lomb Incorporated
Vitrectomy
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
- Trial name
- NCT00412958
- Testing
- Ocriplasmin 25µg, Ocriplasmin 75µg, Ocriplasmin 125µg
- Where
- 20 sites in United States
- Volunteers
- 125 people
- Sponsor
- ThromboGenics
Chronic Low Back Pain
Five-Plus Year Follow-Up of SMART Randomized Controlled Trial
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
- Trial name
- SMART (NCT03997825)
- Testing
- Basivertebral Nerve (BVN) Ablation
- Where
- 13 sites in United States
- Volunteers
- 117 people
- Sponsor
- Relievant Medsystems, Inc.
Aphakia, Cataract
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
- Trial name
- NCT01292629
- Testing
- iSert 251 intraocular lens
- Where
- 5 sites in United States
- Volunteers
- 125 people
- Sponsor
- Hoya Surgical Optics, Inc.
Staphylococcal Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of…
- Trial name
- STRIVE (NCT02388165)
- Testing
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
- Where
- 301 sites in United States, Austria and 9 more
- Volunteers
- 3,450 people
- Sponsor
- Pfizer
Arthroplasty, Replacement, Hip, Blood Transfusion
Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who…
- Conditions
- Arthroplasty, Replacement, Hip, Blood Transfusion, Blood Transfusion, Autologous
- Trial name
- NCT00822588
- Testing
- Sangvia® System
- Where
- 6 sites in Austria, Netherlands and 2 more
- Volunteers
- 227 people
- Sponsor
- Wellspect HealthCare
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
Jaw, Edentulous, Partially
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla.
- Trial name
- NCT00748241
- Testing
- Astra Tech Fixture ST
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Failed Back Surgery Syndrome, Post-laminectomy Syndrome
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.
- Trial name
- SubQStim (NCT01818297)
- Testing
- PrimeAdvanced® neurostimulator system
- Where
- 27 sites in United States
- Volunteers
- 137 people
- Sponsor
- MedtronicNeuro