Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)

Completed

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00951938

Run by

Orthofix Inc.

People needed

200

Starts

2009-08-01

Expected to finish

2012-08-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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