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Spine Research

The following are research studies conducted by OrthoIndy spine surgeons.
You can also visit ClinicalTrials.gov for more information. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
ClinicalTrials.gov
 

Title: A complete evaluation including outcomes and cost-analysis of a Transforaminal Lumbar Interbody Fusion (TLIF) population at a specialty hospital.
Sponsor: Investigator Initiated
Investigators: Drs. Dietz, Coscia, Huler, Schwartz, Trammell, Jackson; Flint, Fitzpatrick
Objective: The primary purpose of this study is to analyze the use of bone grafts (specifically INFUSE) and potential complications that may have occurred in TLIFs.

Title: Osteocel® Plus in Anterior Lumbar Fusion (ALIF): Evaluation of Radiographic and Patient Outcomes
Sponsor: Nuvasive
Investigators: Drs. Schwartz, Dietz, Trammell
Objective: This study is being done to obtain information about the use of Osteocel Plus as a graft substitute versus the other options that are currently available.

Title: A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients with Lumbar Degenerative Disc Disease
Sponsor: Medtronic
Investigators: Drs. Schwartz, Dietz
Objective: The purpose of this study is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System for the treatment of single-level degenerative disc disease in your lumbar spine.

Title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following Product:  The Polaris Deformity System
Sponsor: Biomet
Investigator: Dr. Trammell
Objective: This study is being done to test the safety and effectiveness of the Polaris Deformity Spinal System for the treatment of spinal deformities in people who are skeletally mature.

Title: A Retrospective Evaluation of the Use of Infuse in the Lumbar and Thoracic Spine
Investigators: Drs. Trammell, Schwartz, Dietz, Huler, Coscia, Jackson. Flint, Fitzpatrick
Sponsor: Investigator Initiated
Objective: The study examines both fusion and complication rates associated with its use in the posterior and anterior thoracic and lumbar spine.

Title: A Retrospective Evaluation of the Use of Infuse in the Cervical Spine
Investigator: Drs. Trammell, Schwartz, Dietz, Huler, Coscia, Jackson
Sponsor: Investigator Initiated
Objective: The study examines both fusion and complication rates associated with its use in the posterior and anterior cervical spine.

Title: Retrospective comparison of infection rates in instrumented and non-instrumented spine surgery
Investigator: Drs. Schwartz, Huler, Jackson, Dietz, Coscia, Dodd, Trammell
Sponsor: Investigator Initiated
Objective: To compare infection rates in instrumented and non-instrumented spine surgery.

Title: Instrumented Lumbar Corpectomy with rhBMP-2 and Mastergraft Putty in 3 Different Devices- A Study in Sheep
Investigator: Dr. Schwartz
Sponsor: Medtronic
Objective: To evaluate two different formulations of rhBMP-2 in tow structural devices and compare them to autograft in an instrumented sheep corpectomy model.

Title: A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc-LP at a Single Level for Symptomatic Cervical Disc Disease.
Investigators: Drs. Schwartz, Dietz, Huler, Coscia
Sponsor: Medtronic
Objective: This study is being conducted to evaluate the safety and effectiveness of the ACD-LP for the single-level surgical treatment of cervical (neck) disc disease.

Title: Comparison of tensional strength of attachment of four multi-axial screw saddles to the bone screw head (pedicle screw)
Investigator: Dr. Trammell
Sponsor: Investigator Initiated
Objective: To design and test a jig used for pedicle screw torsional, 2-axis rotational plane evaluation.

 

Registry Studies

Spine Surgery Database (Spine Database #1)
Spine Surgeons Oswestry and Neck Pain Disability Index Outcomes Study (Spine Database #2)

 

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