Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF) (TLF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.
ClinicalTrials.gov Identifier:
NCT00965380
First received: August 21, 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 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.


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 Posterior Lumbar or Transforaminal Lumbar Interbody Fusion (PLIF or TLIF)

Further study details as provided by Orthofix Inc.:

Primary Outcome Measures:
  • Fusion Rates for Trinity Evolution [ Time Frame: Operative to 24 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-op to 24 months follow-up ] [ Designated as safety issue: No ]
  • Complication Rates for Trinity Evolution [ Time Frame: Operative to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Degenerative disorders of the lumbar spine can lead to a multitude of clinical problems including back pain and/or leg pain secondary to nerve compression and/or deformity. When conservative (non-surgical) treatment fails after at least a 6 month period and/or non-operative treatment is not indicated, patients and physicians may turn to a surgical solution. Surgical options consist basically of decompressing nerves, correcting and/or stabilizing deformities if required and fusing the segment, depending on the clinical situation. 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 a 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

Patients with symptomatic lumbar degenerative disc disease scheduled to undergo PLIF or TLIF.

Criteria

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 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.

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).
  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: NCT00965380

Locations
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
United States, Connecticut
Total Spine Care
Canton, Connecticut, United States, 06019
Middlesex Orthopedic Surgeons
Middletown, Connecticut, United States, 06457
Center for Advanced Neuro and Spine
New Britain, Connecticut, United States, 06051
United States, Georgia
Optim Healthcare (Formerly Southeastern Orthopedic Center)
Savannah, Georgia, United States, 31405
United States, Illinois
Parkview Orthopaedic Group
Palos Heights, Illinois, United States, 60463
United States, Louisiana
Willis Knighton Health System
Shreveport, Louisiana, United States, 71105
United States, Michigan
University of Michigan A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Cooper University Neurological Institute
Camden, New Jersey, United States, 08103
United States, New York
Spine Surgery of Buffalo Niagara
Niagara Falls, New York, United States, 14304
United States, North Carolina
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, United States, 28204
Duke University
Durham, North Carolina, United States, 27710
Triangle Orthopaedic Associates
Durham, North Carolina, United States, 27704
Triangle Neurosurgery
Raleigh, North Carolina, United States, 27607
United States, Virginia
Tuckahoe Orthopedic Surgeons
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Orthofix Inc.
Investigators
Study Director: Raymond J. Linovitz, MD Orthofix Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT00965380     History of Changes
Other Study ID Numbers: CP-01006B
Study First Received: August 21, 2009
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Orthofix Inc.:
Trinity Evolution
Symptomatic lumbar degenerative disc disease
Posterior lumbar interbody fusion
Transforaminal lumbar interbody fusion

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

ClinicalTrials.gov processed this record on September 16, 2014