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Degenerative Disc Disease

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

Sponsored by Orthofix Inc.

About this trial

Last updated 7 years ago

Study ID

CP-01006B

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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).