Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.

This area of research includes:

• Mechanisms of human disease
• Therapeutic interventions
• Clinical trials
• Development of new technologies
• Epidemiologic and behavioral studies
• Outcomes research and health services research

At TOA, we define research as the study of new medications or devices which are intended to improve the quality or the availability of a treatment for a given disease or symptom.

Patients also benefit in an indirect manner by having access to some therapeutic and diagnostic services, at no charge to them.

All patients who contemplate participation in clinical research will first be provided with detailed informed consent literature, which will allow them to make an independent decision about whether or not they choose to volunteer. Finally, a person's decision to participate, or not, in clinical research will never, in any way, impact the quality or nature of the care they receive from TOA.

Our active clinical research program also includes clinical trials of new medications under study for rheumatic diseases. We have participated in clinical trials of most of the rheumatoid arthritis medications that have become available over the past 20 years including Enbrel, Humira, Orencia, Rituxan, Kineret, Actemra, and Cimzia as well as the major anti-inflammatory medications. We have also collaborated with researchers at Duke University and the University of North Carolina's Thurston Arthritis Research Center. In our opinion, the availability of clinical trials is a major resource for our patients allowing them access to cutting edge therapies when established medications are not satisfactory. Our participation also keeps us at the forefront of the newest advances in rheumatology. If you are interested in participating in a clinical trial, please contact us at 919-281-1968 or at tgulledge@triangleortho.com.

This trial is a multi-centered, randomized, unmasked, longitudinal evaluation of the safety and efficacy of the Freedom Lumbar Disc (FLD) total disc replacement device. The comparator device is the Prodisc-L (Synthes Corporation).

For information about this study please contact: Crystal Hill at (919) 281-1870 or email at chill@triangleortho.com.

The purpose of this study is to evaluate the effectiveness of a decompression using the iO-Flex® System in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis compared to objective performance criteria (OPC) established by current surgical standard of care.

For information about this study please contact: Crystal Hill at (919) 281-1870 or email at chill@triangleortho.com.

This multi-center, prospective, randomized controlled trial is designed to evaluate the safety and effectiveness of the DISCOVER™ Artificial Cervical Disc when compared to ACDF for the treatment of cervical Degenerative Disc Disease.

Requirements:

• Five Year Follow-up
• Multiple x-ray studies
• Four Axial CT scans
• Patient agrees to randomization. Study will be in a 2:1 ratio, stratified separately within 1- and 2-level applications, favoring the artificial disc.
• Follow-up appointments at 2 and 6 weeks, 3, 6, 12, 24, 36, 48, and 60 months

For information about this study please contact: Chris Zito at (919) 281-1720 or email at czito@triangleortho.com.

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.

Requirements:

• 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 PLIF approach 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.

For more information contact Crystal Hill at (919) 281-1784 or chill@triangleortho.com.

The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion.

Inclusion Criteria:

• Symptomatic cervical degenerative disc disease at up to four levels between C3 and T1
• Neck and/or arm pain and/or a functional neurological deficit, and/or cervical myelopathy with neural compression confirmed by plain x-rays and MRI, Myelogram or CT. Scheduled for an ACDF with a spacer and anterior supplement fixation of the surgeon's choice.
• Greater than 18 years of age
• Unresponsive to conservative care over a period of at least 6 weeks 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:

• More than 4 levels (C3 - T1) requiring surgical treatment
• 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.
• Axial neck pain as the primary diagnosis, without evidence of neural compression
• Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution 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

For information about this study please contact: Crystal Hill at (919) 281-1784 or email at chill@triangleortho.com.

This trial is a multi-center, randomized study comparing the Vertiflex Superion Interspinous Spacer (ISS) to the X-Stop interspinous process decompression (IPD) System in patients with Moderate Lumbar Spinal Stenosis.

For information about this study please contact: Chris Zito at (919) 281-1720 or email at czito@triangleortho.com.

The iO-Flex™ Study is a multi-center evaluation of the Baxano iO-Flex™ System for Single-Level, Decompressive Lumbar Surgery.

For information about this study please contact: Crystal Hill at (919) 281-1870 or email chill@triangleortho.com.

This is a multi-center evaluation of the Crosstrees™ PVA pod system in symptomatic Adult Patient with Acute Vertebral Body Compression Fractures at T4-L5.

For information about this study please contact: Crystal Hill at (919) 281-1870 or email chill@triangleortho.com.

Study of the Wallis® System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine.

For information about this study please contact: Crystal Hill at (919) 281-1870 or email chill@triangleortho.com.

The purpose of this trial is to assess whether the Stabilimax NZ™ is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one or two contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications.
NO LONGER ENROLLING FOR THIS STUDY.

Call Crystal Hill, CCRC at (919) 281-1870.
chill@triangleortho.com

Triangle Orthopaedics is currently seeking patients for participation in an artificial disc trial. Patients who wish to participate in this trial must be referred by one of the surgeons. If eligible, the patient will receive either the FDA-approved Charité artificial disc, or the Spinal Motions Kineflex lumbar disc. For patients electing to participate in the cervical trial, they will receive either the Spinal Motions Kineflex-C artificial cervical disc or cervical fusion. Participants must be 18-60 years of age, and have at least six months of documented treatment for back (lumbar) or neck (cervical) pain.

For information about this study please contact: Sandra Broadwater at (919) 281-1720 or email at sbroadwater@triangleortho.com.

• http://www.spine-health.com/research/trials/kineflex/kineflex01.html
• http://www.spine-health.com/research/trials/kineflex_cerv/kineflex_cerv01.html

Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease.
NO LONGER ENROLLING FOR THIS STUDY.

For information about this study please contact: Chris Zito at (919) 281-1720 or email at czito@triangleortho.com.

This is an open-label study in healthy men and women who have been cleared medically for elective total hip replacement surgery. This study is examining the penetration of Ceftobiprole into bone.

Ceftobiprole is a new chemical entity with bactericidal activity being studied in the treatment of the complicated skin and skin structure infections (cSSI), nosocomial pneumonia (NP), and community acquired pneumonia in hospitalized patients (hCAP).

NO LONGER ENROLLING FOR THIS STUDY.

This is an Open Label Phase I/II Pilot Study to Evaluate the safety and tolerability of NuQu and the injection procedure employed to deliver NuQu to the nucleus pulposus of degenerated intervertebral discs. The study will also assess the activity of NuQu through evaluation of preliminary effectiveness in relieving back pain.

NuQu™ is a cryopreserved suspension of culture-expanded, allogeneic human juvenile chondrocytes intended for injection into the lumbar disc nucleus using commercially prepared fibrin carrier.

Inclusion Criteria (abbreviated list) –

1. Have provided consent by signing the Institutional Review Board approved Informed Consent;
2. Are male or female between the age of 18 to 70 years of age;
3. If female, must have a negative pregnancy test at the time of treatment, be actively practicing contraception or abstinence, be surgically sterilized or be postmenopausal;
4. Have central low back pain aggravated by movement and or postural changes (standing/sitting);
5. Have tried and failed at least 12 weeks of conservative management as directed by a licensed physician, chiropractor and or physical therapist. Treatment must include any or a combination of physical therapy, chiropractic care or pain management. This may include but is not limited to rest or activating physical therapy, heat, cold, electrical stimulation, ultrasound, manipulation, acupuncture, analgesics including narcotics (with no history of abuse) anti-inflammatory medication and radiofrequency and spinal injections;
6. Have been and refused the alternate treatment alternatives of steroid use, spinal injection, nerve ablation and surgical intervention;

For more information contact Crystal Hill at (919) 281-1870 or chill@triangleortho.com

A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of an investigational compound to be combined with MasterGraftTM Matrix in Subjects Undergoing Lumbar Interbody Fusion with Instrumentation via a Posterior Approach.

Requirements:

• Male or Female (Females can not be pregnant or breastfeeding.
• 18 to 70 years of age
• Diagnosed with degenerative disc disease (DDD)
  • in 1 or 2 adjacent vertebral levels between L1 and S1
  • with or without spinal stenosis and
  • with or without Grade II degenerative spondylolisthesis or spinal stenosis.
• Subjects must have clinical symptoms of DDD and have failed 6 months of non-operative management.

If you would like to learn more about this study please contact Crystal Hill at (919) 281-1870 or by email at chill@triangleortho.com

Designed to Study the Efficacy and Safety of OMS103HP with Vehicle in Patients Undergoing Autograft ACL Reconstruction.

Call Crystal Hill, CCRC at (919) 281-1870.
chill@triangleortho.com

The purpose of this registry is to collect outcome information following lumbar disc replacement surgery done using the Kineflex™.
NO LONGER ENROLLING FOR THIS STUDY

The purpose of this registry is to collect outcome information following lumbar disc replacement surgery done using the Kineflex™.
NO LONGER ENROLLING FOR THIS STUDY

Spinal Motion (Continued Access Lumbar)
The purpose of this registry is to collect outcome information following lumbar disc replacement surgery done using the Kineflex™. NO LONGER ENROLLING FOR THIS STUDY

Spinal Motion (Continued Access Cervical)
The purpose of this registry is to collect outcome information following cervical disc replacement surgery done using the Kineflex™. NO LONGER ENROLLING FOR THIS STUDY

For information about this study please contact: Chris Zito at (919) 281-1720 or email at czito@triangleortho.com.