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

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 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.

Key facts

Study ID

NCT00965380

Run by

Orthofix Inc.

People needed

207

Starts

2009-09-01

Expected to finish

2015-01-01

Last updated by the study team

2018-10-23

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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