Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951938
• Other study ID #: CP-01005A
• Status: Completed
• Phase: N/A
• First received: July 31, 2009
• Last updated: April 7, 2014
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: Orthofix Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

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	Carolina NeuroSurgery & Spine	Charlotte	North Carolina
United States	CORE Orthopaedic Medical Center	Encinitas	California
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Western Regional Center for Spine and Brain Surgery	Las Vegas	Nevada
United States	Central Connecticut Neurosurgery and Spine	New Britain	Connecticut
United States	Denver-Vail Orthopedics, P.C.	Parker	Colorado
United States	Jefferson Medical College	Philadelphia	Pennsylvania
United States	Triangle Neurosurgery	Raleigh	North Carolina
United States	Shasta Orthopaedics Spine Center	Redding	California
United States	The Virginia Spine Institute	Reston	Virginia
United States	Tuckahoe Orthopaedic Associates	Richmond	Virginia
United States	Greater Houston Neurosurgery Center	The Woodlands	Texas

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 12 months Follow-up	No
Secondary	NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function		Pre-operative to 12 months follow-up	No
Secondary	Complication Rates for Trinity Evolution		Operative to 12 months follow-up	Yes