Clinical Trials: Current Studies

“Clinical investigation of the SB Charite III intervertebral disc spacer”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Link Spine Group, Inc.

Investigational Product: SB Charité III Intervertebral Dynamic Disc Spacer (Artificial Disc)

The objective of this study is to evaluate the safety and effectiveness of the SB Charité III Artificial Disc. In the first phase of the study, the SB Charité III Artificial Disc was compared to the BAK® Interbody Fusion Cage (BAK Cage) for treatment of single level degenerative disc disease. Eligible patients must not have prior fusion or other spinal surgery, except prior discectomy, laminotomy/laminectomy (without accompanying facetotomy), or nucleolysis at the same level to be treated. In the second phase of the study, eligible patients are being treated with only the SB Charité III Artificial Disc.

Preliminary Eligibility Criteria: Patient

• Has single level degenerative disk disease at L4/L5 or L5/S1
• Has had at least six months of conservative treatment
• Has had fewer than three previous abdominal procedures
• Is between 18 - 60 years of age
• Has never had a previous fusion attempt at the involved level

“Autologous growth factors (AGF) as an adjunct to autologous bone vs. autologous bone alone in posterolateral lumbar arthrodesis to enhance bony growth”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Interpore Cross International

This study is a multicenter patient and radiologist blinded clinical trial our clinical research group is participating in and managing. Two sites are open for enrollment: CINN and the Illinois Bone and Joint Institute (Dr. Jesse Butler). This study evaluates the efficacy of Autologous Growth Factors in promoting and increasing the rate of bone growth, bone density and bone volume following instrumented posterolateral fusions with autologous bone graft. The objective is to evaluate the volume of healed bone in a posterolateral arthrodesis site when compared to the opposite side treated with Autologous Growth Factors.

Preliminary Eligibility Criteria: Patient

• Has one, two or three (consecutive) level degenerative disk disease between L1 to S1
• Has had at least three months of conservative treatment
• Is skeletally mature between 21 - 80 years of age
• Has had fewer than three previous open, posterior lumbar procedures at the involved level(s)

“A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by DePuy AcroMed

The purpose of this research study is to determine the safety and effectiveness of the Cervical I/F Cage for Anterior Cervical Interbody Fusion. This study will evaluate the effectiveness and safety of this device as compared to two current methods of treating degenerative disc disease. We will compare the safety and effectiveness of the Cervical I/F Cage to the standard treatment using allograft with plating. The current standard includes the use of autograft with or without plating and allograft with plating. Efficacy will be evaluated clinically and radiographically. Safety will be assessed by the collection of reported clinical complications and adverse events. This carbon fiber polymer device is an interbody fusion cage designed to give mechanical support to the cervical spine while autograft material housed within the device forms the required fusion mass to treat the patient’s condition. The device is expected to produce improved fusion when compared to grafting with plates (a current standard of treatment).

Preliminary Eligibility Criteria: Patient

• Has degenerative disk disease at one or two adjacent levels between C4 to C7
• Has had at least six weeks of neck and/or shoulder and arm pain
• Must not have had prior surgical treatment of the cervical area (laminotomy or foraminotomy allowed)
• Is between 18 - 70 years of age

“PolyLok™ Lumbar Interbody Fusion Device IDE Clinical Study”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Cortek, Inc.

The purpose of this investigation is to evaluate the safety and effectiveness of the PolyLok Lumbar IBF Device (investigational) as compared to the BAK device (control) for the treatment of degenerative disc disease (DDD) at a single level in the lumbar spine. Only the PolyLok Device will be implanted for study purposes at CINN. This study is designed to test the hypothesis that the overall success rate of the subjects treated with the PolyLok Lumbar IBF Device is similar to the overall success rate for the subjects treated with the BAK device for single level lumbar DDD. In addition, the study tests the hypothesis that the complication and further surgery rates are no worse in the treatment subjects than in the control subjects. The primary efficacy endpoints for the investigation are fusion, pain and function, and neurological status.

Preliminary Eligibility Criteria: Patient

• Has one level degenerative disk disease between L2 to S1
• Has had at least six months of non-operative treatment
• Is between 18 - 65 years of age
• Has had prior anterior spinal surgery or fusion attempt at the involved level

“Humanitarian Device Exemption: Telescopic Plate Spacer Spinal System for Use In Patients with Metastatic Spine Disease Following Vertebrectomy/Corpectomy”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Interpore Cross International

The Telescopic Plate Spacer (TPS™) is a device which has a Humanitarian Device Exemption granted by the FDA. A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects fewer than 4,000 individuals in the United States per year and for which no comparable device is available. The FDA permits the use of Humanitarian Use Devices based primarily on evidence that it does not pose a significant risk of injury to the patient and that the potential benefit of the device to the health of the patient outweighs the risks of its use. No clinical research or data collection will be conducted with this device.

The Telescopic Plate Spacer (TPS™) is a device used in the treatment of patients who have a tumor in their cervical spine (neck or upper back) that requires removal of the tumor. For some of these patients, the location of their tumor causes one or more of the bones in their neck to become unstable. In order to remove the tumor, a surgeon must also remove one or more of the bones in the spine. The TPS Spinal System is designed to stabilize and align the spine and reduce compression of the spinal cord.

"Cortek Connect Cervical Allograft Patient Registry Study”

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Cortek, Inc.

This is a study designed to gather data for a publication relating to and marketing purposes of the product. Connect is already approved by the FDA, but the Sponsor wishes to collect data from patients who receive this product during a 1, 2 or 3 level anterior cervical fusion. The study will be approximately 18 months in length and CINN plans to enroll a maximum of 20 patients to the study.

"Clinical Outcome of Lumbar Degenerative Disc Disease Treated with PLIF (Posterior Lumbar Interbody Fusion) Allograft Spacer"

Mitchell Gropper, M.D. (Principal Investigator - Community & Rush)
Fred H. Geisler, M.D., Ph.D (Co-Investigator - NOIC)
Sponsored by Synthes Spine

Investigational Product: PLIF Allograft Spacer (FDA Approved)
The primary objective is to accurately define the clinical benefits of the PLIF Allograft Spacer in treating lumbar degenerative disc disease in patients requiring lumbar fusion.

Preliminary Eligibility Criteria: Patient

• Has one or two level (consecutive) degenerative disk disease between L2 and S1
• Has experienced pain, functional deficit and/or neurological deficit for a minimum six months
• Has failed to respond to non-operative treatment for a minimum six months
• Is skeletally mature and at least 18 years of age
• Has never had a previous fusion attempt at the involved level(s)
• Has not had more than two previous open, posterior, lumbar spine surgical procedures at the involved level(s)

"A randomized controlled trial of Grafton® demineralized bone matrix putty versus iliac crest autologous bone in lumbar spine fusion procedures"

Fred H. Geisler, M.D., Ph.D (Principal Investigator)
Sponsored by Osteotech, Inc.

This study evaluates whether a form of allograft bone tissue (Grafton® demineralized bone matrix putty) is similar to the use of autograft tissue in the development of new bone after lumbar spinal fusion. Patients who are diagnosed with degenerative disc disease or degenerative spondylolisthesis (Grades I, II or III) and were scheduled to have one or two levels fused.

Enrollment of new patients to this study is closed.

"Controlled, double-blind, randomized efficacy and safety evaluation of Hylagel‚ (hylan G-F 80) for reducing post-surgical perineural adhesion/scarring in patients undergoing intraspinal lumbar surgical procedures for herniated lumbar intervertebral disc”

Fred H. Geisler, M.D., Ph.D (Principal Investigator - NOIC)
Sponsored by Genzyme Corporation

Investigational Product: Hylagel® (hylan F-G80)
The object of this study is to determine the efficacy and safety of the experimental agent, Hylagel“. The effectiveness of Hylagel“ is being compared to usual treatment in the reduction of scar formation and associated pain and disability following spine surgery.