Clinical Trials

Outcome Measures:

Primary Outcome Measures

• Improvement in Zurich Claudication Questionnaire Physical Function and Symptom Severity Scores [Time Frame: 24 months]
• Lack of device related serious adverse events [Time Frame: 24 Months]
• Maintenance or improvement in Neurological status. [Time Frame: 24 months]
• No device failures requiring revision, removal, re-operation or supplemental fixation. [Time Frame: 24 Months]

Secondary Outcome Measures

• Improvement in pain as measured by Visual Analog Scale [Time Frame: 24 months]
• Radiological evidence of fusion in Investigational Group [Time Frame: 24 months]

Eligibility

Ages Eligible for Study: 21 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria

• 21-85 years of age and skeletally mature;
• Have undergone 6 months of non-operative treatment prior to surgery;
• Lateral, lateral recess and/or central canal stenosis;
• Disc height measuring ≥ 4 mm at the operative level;
• Persistent leg, thigh and/or buttock symptoms, including pain, numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;
• A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;
• A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;
• A candidate for a decompression with full facetectomy at the operative level
• Candidate for a posterior lumbar fusion;
• Physically and mentally willing and able to comply evaluations;
• Lives in the immediate area and has no plans to relocate;

Exclusion Criteria

• Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
• Previous lumbar fusion or disc replacement procedure;
• Osteoporosis;
• Greater than Grade I spondylolisthesis or retrolithesis;
• Spondylolisthesis at levels other than at the operative level;
• Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity);
• Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;
• Acute traumatic pars fracture at the operative/adjacent level vertebral body;
• Spinal stenosis at more than three lumbar segments;
• Acute trauma to the lumbar spine within the last 24 months;
• Active infection at the operative level, or a systemic infection;
• Physically / mentally compromised;
• Systemic disease that would affect the patient's welfare or the research study.
• Immunologically suppressed or immunocompromised;
• Insulin-Dependent Diabetes Mellitus (Type I Diabetes);
• Currently undergoing long-term steroid therapy;
• Metabolic bone disease;
• Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;
• Known allergy to cobalt chromium or titanium;
• Used any investigational drug or device within the past 30 days;
• Pending litigation or receiving Workers Compensation related to back pain or injury;
• Is a prisoner.

Primary Outcome Measures:

• Time to Hemostasis (TTH) [Time Frame: Within 5 minutes of treatment]

Secondary Outcome Measures:

• Incidence, severity and relationship of Adverse Events [Time Frame: During 4 wks post-treatment]
• Incidence of Hemostasis [Time Frame: 3 and 5 minutes post-treatment]

Eligibility

Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
• Subject is undergoing one of the 4 surgical procedures described
• Subject age is >18 years at time of consent
• If female and of child-bearing potential, subject has negative pregnancy test within 14 days prior to treatment and is not breast-feeding
• If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
• Mild to moderate surgical bleeding

Exclusion Criteria:

• Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
• Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
• Subject has known allergy to porcine gelatin
• Subject is unwilling to receive blood products
• Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
• Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
• Platelets < 100 x109 PLT/L during screening

Primary Outcome Measures:

• Post-operative CSF leaks [Time Frame: 90 days post-operative]

Secondary Outcome Measures:

• Post-operative surgical site infections [Time Frame: 90 days post-operative]
• Post-operative neurological serious adverse events [Time Frame: 90 days post-operative]

Eligibility

Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria (Prospective Treatment Arm):

• Subject is 18 years of age or older
• Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board.
• Subjects that have a dural opening/tear will be treated with DuraSeal. However, in some instances, there may be an occasion where the investigator chooses not to use DuraSeal due to a specific surgical reason.

Exclusion Criteria (Prospective Treatment Arm):

• The investigator determines that the subject will not be able to comply with the required follow-up visits
• Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)

Inclusion Criteria (Retrospective Control Arm):

• Subject is 18 years of age or older
• Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred
• Informed consent has been provided by the subject (if required by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria (Retrospective Control Arm):

• Subject has received DuraSeal Sealant (either cranial or spinal) during the target procedure
• Pregnant or breastfeeding females (as documented in the medical records)

Purpose

The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.

Primary Outcome Measures:

• Fusion Rates for Trinity Evolution

Secondary Outcome Measures:

• NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function
• Complication Rates for Trinity Evolution

Inclusion Criteria:

• Symptomatic lumbar degenerative disc disease at 1 or 2 adjacent levels between L3 and S1
• Patients with back and/or leg pain scheduled for stabilization with or without decompression via a TLIF or PLIFapproach utilizing an interbody spacer and supplemental posterior fixation.
• Greater than 18 years of age
• Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent.

Exclusion Criteria:

• Patients requiring surgical treatment other than at 1 or 2 adjacent levels between L3 and S1
• Active local or systemic infection
• Currently pregnant or considering becoming pregnant during the follow-up period
• Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year
• Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution matrix in and around the interbody spacer.
• Use of adjunctive post-operative stimulation
• Prior interbody surgery at the same level
• Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).

Participants in the trial are randomly selected to receive the Wallis device or a total lumbar disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine. The artificial disc is a FDA-approved, commercially-available implant designed to replace an entire diseased or damaged spinal disc through a surgery called “total disc replacement” (TDR). The Wallis System is designed to treat the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.

Boulder Neurosurgical & Spine Associates (BNA) believes that by offering this clinical trial, it reinforces its commitment to give patients access to the latest investigational treatments for back pain.

Study objectives

The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is equivalent to total disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine at the L4 – L5 level.

Study overview

Approximately 25 medical centers are enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System in the treatment of mild to moderate degenerative disc disease.

The study is randomized so that 50 percent of the study participants will receive a Wallis device and 50 percent will receive a commercially available artificial disc (either the CHARITÉ® or PRODISC-L® artificial disc). Patients will be randomly assigned to receive either surgical option.

Study participants will receive all study-related tests and surgical procedures at no charge.

In contrast to traditional fusion surgery, in which two or more vertebrae are fused together, the Wallis device and lumbar artificial discs are motion-preservation technologies that allow the spine to continue to move. The Wallis device is placed between the spinous processes – ridges of the spine – and acts as a stabilizing spacer that may relieve symptoms of degenerative disc disease.

What does it mean to have a Total Disc Replacement?

Total Disc Replacement (TDR) is a surgical procedure in which a diseased or damaged disc is replaced with a mechanical device (artificial disc) that behaves similarly to the body’s natural disc. Artificial discs have been approved by the FDA for sale in the United States. Like many spinal implants, an artificial disc (TDR) is implanted using an anterior approach, which means the surgeon inserts the device through an incision made near your belly button. The primary advantage of receiving the TDR is that, unlike current fusion implants used to treat degenerative discs, the design of the TDR device allows the treated area of the spine to maintain movement.

What are the potential benefits?

• May relieve pain without necessitating spinal fusion.
• Possibly preserves motion at the affected level unlike other surgical choices.
• The procedure may prevent adjacent level disc disease; a common problem associated with fusion surgeries.

What are the potential risks?

• May not relieve all of the patient’s back pain, or could potentially make it worse.
• The surgery is conducted through the abdomen rather than through the back. This can be more invasive.
• May complicate the need for further surgical intervention, such as a fusion in the event that symptoms persist.
• As with all surgeries, surgery-related complications may occur.

What is the Wallis device?

The Wallis device is a spinal implant that is surgically inserted between the bones in your back (called vertebrae). The device is designated to relieve low back pain caused by degeneration or damage to a disc in your spine. Disc degeneration can change the normal sagittal movements of and overall strength of the spine. Additionally, a degenerated disc may lose its ability to act as a shock absorber, which is important for day-to-day, pain-free living. These problems can progress to persistent low back pain.

The Wallis device attempts to restabilize or support the spine during the early stages of degeneration. It also aims to slow the breakdown of the disc while still allowing the spine to move normally.

The Wallis device is implanted using a posterior approach, which means it is inserted through a small incision in your back.

Click to watch a surgical animation.

Has it been used before?

The Wallis device was originally developed in Bordeaux, France and has been in use in various parts of the world since 1986. Outside the US, more than 12,000 patients have been treated with the Wallis device. Up to this point, the FDA has not cleared Wallis for the use in the United States. The aim of the Wallis study is to gain approval for the use here.

Who is a good candidate for the study?

The Wallis study is intended for people with mild degenerative disc disease in the lumbar spine. The cost of the Wallis or disc replacement procedure will be covered by the study.

Patients must also meet the following criteria in order to take part in the Wallis study:

• Age 18 – 60
• Have experienced at least six months of failed non-surgical or “conservative care” treatments (physical therapy, medications, back injection, etc.)
• Voluntarily read and sign the informed consent document

Who is not a good candidate for the study?

If one or more of the following apply, you will not be able to take part in the study:

• Disc problems at other than the L4-L5 levels
• Leg pain greater than back pain
• Unwilling to undergo surgery
• Bacterial infection
• Poor bone quality
• HIV or Hepatitis
• Lumbar Stenosis
• Pregnant
• Uncontrolled Diabetes
• Extreme obesity
• Prior participation in a clinical study of any investigational spinal implant or spinal treatment
• Previous fusion at the same or adjacent levels being studied

What are potential benefits?

• May relieve pain without requiring spinal fusion.
• Surgery is relatively conservative when compared to other surgical choices, like fusion or disc replacement.
• The Wallis procedure does not prevent the need for another procedure (e.g., fusion or disc replacement) if problems persist.

What are potential risks?

• May not relieve all of the patient’s back pain, or could potentially make it worse.
• Patient potentially could develop instability after surgery.
• As with all surgeries, surgery-related complications may occur.

To read more about this clinical trial please dowload the PDF, or contact us at 303-938-5700 if you have any questions.

To read about patient experience wallissurgery.blogspot.com.

Figure: Advent Cervical Artificial Disc.

The purpose of the research study is to evaluate the safety and effectiveness of the Advent™ Cervical Disc in patients who have neck problems and that require surgery to replace the disc found between the cervical vertebrae following discectomy. Patients that have failed conservative treatment for at least six weeks for nerve root and/or spinal cord compression due a herniated disc and/or osteophyte formation between C3 and C7 may be eligible for enrollment in the study. Enrollment eligibility will be confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, X-rays, etc.).

Caution: Investigational Device – Limited by Federal Law to Investigational Use

A multicenter clinical study was initiated in the United States in the spring of 2003 and was completed in 2012. The clinical trial data will be submitted for approval by the US Food and Drug Administration (FDA) to commercialize the implant.

The purpose of this clinical trial is to evaluate the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4 to S1. Patients who enroll in the clinical study are randomly assigned a treatment group. Approximately two-thirds of the patients receive the MAVERICK™ Artificial Disc and one-third of the patients receive the lumbar fusion.

Caution: Investigational device. Limited by Federal (United States) law to investigational use.

In order to perform the brain surgery, the surgeon will cut through the skull (a procedure is known as a craniotomy) and through the dura (one of the tissue layers covering the brain). The space between the dura and the brain is filled with cerebral spinal fluid called CSF. The use of a sealant on top of the sutures used to close the opening in the dura may help control CSF leakage after the surgery. The product to be studied, Fibrin Sealant, Vapor Heated, Solvent/Detergent 500 s-apr (FS VH S/D 500 s-apr), is a fibrin sealant known as a surgical “glue” made out of two substances naturally found in the human body, thrombin and fibrinogen. When mixed together, they help to form a clot. The human body naturally absorbs the clot over a period of about 14 days.

This study will also look at how often infection occurs, if there are any side effects from the sealant, and what are the procedures required to treat CSF leakage after surgery. FS VH S/D 500 s-apr is investigational and is not approved by the U.S. Food and Drug Administration (FDA) for sealing dura sutures in the USA.

The Cancer Patient Fracture Evaluation (CAFE) study is designed to compare the safety and effectiveness of two alternative treatments for painful, acute VCFs: a surgical treatment known as Balloon Kyphoplasty and non-surgical treatment.

Balloon Kyphoplasty is a minimally invasive spine procedure that has been shown in non-randomized clinical trials to relieve pain, improve function and quality of life, restore vertebral height and correct spinal deformity. To date over 210,000 patients worldwide have had VCFs treated with Balloon Kyphoplasty. Traditional non-surgical treatments for spinal fractures in cancer patients include bed rest, medication, back bracing, walking aids, radiation, and physical therapy.

The US Food and Drug Administration (FDA) has already cleared devices for use in Balloon Kyphoplasty for the treatment of VCFs in cancer patients. The purpose of this postapproval, randomized, controlled clinical trial is to collect further evidence that may support the Balloon Kyphoplasty treatment option. The study will evaluate a total of 200 patients at up to 30 centers across the United States, Canada, Europe and Australia.

BNA has joined the CAFE trial as part of its dedication to improving the quality of life for people with cancer. Dr. Alan Villavicencio is one of the first to bring this new treatment option for cancer patients in Colorado and will be performing the Balloon Kyphoplasty procedures