Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.
ClinicalTrials.gov Identifier:
NCT00951938
First received: July 31, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental anterior 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 upper extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.


Condition
Degenerative Disc Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) in Patients Undergoing Anterior Cervical Discectomy and Fusion

Further study details as provided by Orthofix Inc.:

Primary Outcome Measures:
  • Fusion Rates for Trinity Evolution [ Time Frame: Operative to 12 months Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function [ Time Frame: Pre-operative to 12 months follow-up ] [ Designated as safety issue: No ]
  • Complication Rates for Trinity Evolution [ Time Frame: Operative to 12 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

When conservative care fails to alleviate the pain and neurological deficits caused by degenerative disc disease in a cervical spine, the most common recourse is surgical decompression of the affected nerves and/or spinal cord. Decompression is often accomplished via an anterior approach whereby essentially the entire disc as well as any bony osteophytes and ligaments that are compressing the spinal cord and/or nerves are removed. While usually successful at decompressing affected neural structures, the decompression often results in collapse of the disc space, instability and recurrent symptomatology.

Most anterior cervical decompressions therefore are followed by insertion of a structural interbody spacer such as a bone graft from the patient's iliac crest (autograft) or a bone graft from a cadaver (allograft). The "gold standard" for aiding healing in spinal fusion surgeries is the harvesting of autograft from the patient's iliac crest and placing it in and around the segments of the spine that are intended to be fused. Autograft is considered the "gold standard" because it contains the essential elements required for successful bone grafting: osteogenesis, osteoconduction, and osteoinduction.

However, the morbidity of harvesting autograft has been well documented and includes chronic donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and prolonged surgical and hospitalization time. There are now a number of products on the market to minimize or replace the use of autograft. However, few of these products contain all three essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction) in a single, stand alone product.

Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject selection will be conducted by patient's neurosurgeon or orthopedic surgeon.

Criteria

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 supplemental 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 reaction to dimethyl sulfoxide (DMSO).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951938

Locations
United States, California
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
Shasta Orthopaedics Spine Center
Redding, California, United States, 96001
United States, Colorado
Denver-Vail Orthopedics, P.C.
Parker, Colorado, United States, 80134
United States, Connecticut
Central Connecticut Neurosurgery and Spine
New Britain, Connecticut, United States, 28204
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
University of Michigan, A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109-5338
United States, Nevada
Western Regional Center for Spine and Brain Surgery
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, United States, 28204
Triangle Neurosurgery
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Greater Houston Neurosurgery Center
The Woodlands, Texas, United States, 77381
United States, Virginia
The Virginia Spine Institute
Reston, Virginia, United States, 20190
Tuckahoe Orthopaedic Associates
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Orthofix Inc.
Investigators
Study Director: Raymond J Linovitz, MD Orthofix Spinal Implants
  More Information

Additional Information:
No publications provided

Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT00951938     History of Changes
Other Study ID Numbers: CP-01005A
Study First Received: July 31, 2009
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Orthofix Inc.:
Trinity Evolution
Anterior Cervical Discectomy and Fusion
Allograft

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014