Indiana Spine Group is currently enrolling patients for the following clinical studies:
Surgical Registries
BioBase Registry
The BioBase Registry, launched in 2019 and sponsored by INNOVASIS, is a prospective, multi-center observational registry tracking outcomes for patients receiving bioactive cervical and lumbar interbody devices. The BioBase electronic data-capturing platform provides Indiana Spine Group with comprehensive surgical outcome analytics that assess changes in pain, quality of life, and fusion rates following lumbar or cervical interbody fusion procedure.
Data collected through the BioBase registry may improve clinical outcomes by optimizing patient selection, predicting risks / benefits, and establishing a national benchmark for outcomes in both lumbar and cervical interbody fusion surgeries. // Dr. John Gorup, Currently enrolling; INNOVASIS.
BioBase Registry Promotional Video
Learn more about the BioBase Registry:
BioBase – Data Registry Overview
Why Innovasis – Cutting Edge Bioactive Solutions
Cervical Spine Registry
The Cervical Spine Research Society or CSRS is the global authority on cervical spine research. The objective of this diagnosis-based observational registry is to develop a clinical registry of patients diagnosed with cervical radiculopathy or cervical myelopathy.
Furthermore, hospitals throughout the U.S. will contribute and provide data on cervical spine diagnoses such as cervical radiculopathy or myelopathy and various cervical surgeries such as cervical foraminotomy, cervical arthroplasty, cervical laminectomy, cervical fusion, anterior cervical discectomy and fusion, cervical laminoplasty or a combination of above.
Data collection will consist of PROMIS Global-10, Neck Disability Index (NDI), Cervical Stiffness Disability Index (CSDI), and if the patient is diagnosed with cervical myelopathy they will complete the Patient reported modified Japanese Orthopaedic Association Questionnaire (P-mJOA).
During follow-up visits, which will occur at 1 and 3 months, and annually 1-5 years post operatively, various items from baseline will continue to be collected with a primary emphasis on the questionnaires.
Registry is established with 11 sites participating to date with 900 patients enrolled with images collected on each patient pre-operatively and post-operatively. Currently enrolling; Cervical Spine Research Society.
Reference: https://www.csrs.org/research/registry
American Spine Registry
The American Spine Registry (ASR) is a collaborative effort of the American Association of Neurological Surgeons (AANS) and the American Academy of Orthopaedic Surgeons (AAOS) on a national quality improvement registry for spine care. Both organizations have joint ownership and leadership representation in this effort. The ASR will transform the Quality Outcomes Database (QOD) Spine Registry, currently the nation’s largest spine Registry, into a more far-reaching program that facilitates the participation of all US-based spine surgeons in a shared, quality data-collection platform.
The ASR leverages the unique data science capabilities of the AANS with the operational expertise of the AAOS Registry Program. The ASR allows both organizations to enhance the scalability, sustainability, ease-of-use and relevance of national spine data collection efforts and facilitates intelligent data use by engaging multiple health care stakeholders in this joint initiative. The participating organizations expect this collaboration will lead to an enhanced ability to use the accumulated information to improve patient care, advance the science of spine surgery, and address the challenges of an evolving, value-based care delivery system.
Since spine surgery is performed by both neurosurgeons and orthopedic surgeons, the development of a common data platform fuels the creation of a consistent, reliable quality information source for all major stakeholders, including physicians, patients, payors, regulatory groups, and industry.
The shared vision for the ASR is to:
- Utilize data to establish benchmarks to test clinical performance and the validity of various quality measures, which are efforts critical to a value-based health care system
- Provide feedback to providers that allows them to continuously improve their practice and health care outcomes using methods applicable to all practice settings
- Reduce data reporting burdens on physicians and allow reuse of data for regulatory requirements and continuous quality improvement programs
- Help inform gaps in knowledge and define areas for further education and research
- Currently enrolling; American Spine Registry.
Reference: https://www.americanspineregistry.org/about-the-american-spine-registry/about-us/
Surgical Trials
Kuros Study
A prospective, randomized, controlled, single-blind, dose-finding, multi-center, parallel group study of the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft for the treatment of patients undergoing single level transforaminal lumbar interbody fusion (the Structure Study) // Dr. Rick Sasso, Currently enrolling; Kuros Biosurgery A.G
Smart Study OR CS2
Centinel Spine Two-Level prodisc® C SK and prodisc® C Vivo Clinical Study WITH Mobi-C as control// Dr. Rick Sasso, Dr. Paul Kraemer, Dr. Joseph Smucker, Currently enrolling
A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc® C SK and prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD); Centinel Spine, LLC
BAGUERA®C Cervical Disc -1 Level
Multi-Center, Prospective, Randomized Clinical Trial, comparing the safety and effectiveness of the BAGUERA®C Cervical disc prosthesis to the MOBI-C® Cervical Disc for the treatment of patients with symptomatic cervical disc disease at a single level//Dr. Rick Sasso, Dr. Paul Kraemer, Dr. Joseph Smucker, Currently enrolling; Spineart USA, Inc
BAGUERA®C Cervical Disc -2 Level
Multi-Center, Prospective, Randomized Clinical Trial, comparing the safety and effectiveness of the BAGUERA®C Cervical disc prosthesis to the MOBI-C® Cervical Disc for the treatment of patients with symptomatic cervical disc disease at a single level//Dr. Rick Sasso, Dr. Paul Kraemer, Dr. Joseph Smucker, Currently enrolling; Spineart USA, Inc
Synergy Cervical Disc -1 Level
A Multi-Center, Prospective, Historically-Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease//Dr. Rick Sasso, Dr. Paul Kraemer, Currently enrolling; Synergy Spine Solutions Ltd
Medtronic PLF IDE Study
Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft with Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions // Dr. Joseph Smucker, Currently enrolling; Medtronic Spine
Medtronic TLIF IDE Study
A Prospective, Randomized, Controlled, Blinded Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System with Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine // Dr. Joseph Smucker, Currently enrolling; Medtronic Spine
Non-Operative Trials
Restore Study
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation – A Post approval marketing trial // Dr. Jonathan Gentile, Dr. Robert Funk, Currently enrolling, Mainstay Medical, US Inc.
Please contact Sheetal Vinayek, 317-715-5897, svinayek@indianaspinegroup.com, for more information about any of our current clinical studies we are enrolling patients for.