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

Degenerative Disc Disease Clinical Trial

— TLF  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965380
• Other study ID #: CP-01006B
• Status: Completed
• Start date: September 2009
• Est. completion date: January 2015

Study information

• Verified date: October 2018
• Source: Orthofix Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	University of Michigan A. Alfred Taubman Health Care Center	Ann Arbor	Michigan
United States	Boulder Neurosurgical Associates	Boulder	Colorado
United States	Cooper University Neurological Institute	Camden	New Jersey
United States	Total Spine Care	Canton	Connecticut
United States	Carolina NeuroSurgery & Spine	Charlotte	North Carolina
United States	Duke University	Durham	North Carolina
United States	Triangle Orthopaedic Associates	Durham	North Carolina
United States	Middlesex Orthopedic Surgeons	Middletown	Connecticut
United States	Center for Advanced Neuro and Spine	New Britain	Connecticut
United States	Spine Surgery of Buffalo Niagara	Niagara Falls	New York
United States	Parkview Orthopaedic Group	Palos Heights	Illinois
United States	Triangle Neurosurgery	Raleigh	North Carolina
United States	Tuckahoe Orthopedic Surgeons	Richmond	Virginia
United States	Optim Healthcare (Formerly Southeastern Orthopedic Center)	Savannah	Georgia
United States	Willis Knighton Health System	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Rates for Trinity Evolution		Operative to 24 months follow-up
Secondary	NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function		Pre-op to 24 months follow-up
Secondary	Complication Rates for Trinity Evolution		Operative to 24 months