Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage

NCT03018392 | Completed Results

• 1 other identifier: TRITANIUM
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.

Conditions

Intervertebral Disc Disease

Outcome Measures

Primary Outcomes (1)

• Fusion Rate

  Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)

  1 year

Study Arms (1)

Tritanium

EXPERIMENTAL

TLIF with Tritanium® PL cage and pedicle screw fixation

Device: Stryker Tritanium Spinal System

Interventions

Stryker Tritanium Spinal System DEVICE

open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications

Tritanium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has one or more of the following diagnoses: degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1, and may also include up to Grade I spondylolisthesis at the involved level(s); degenerative scoliosis for which the Tritanium PL cage will be used as an adjunct to fusion
• Skeletally mature and ≥ 18 years old at time of enrollment
• Completed at least 6 months of non-operative therapy prior to surgery
• Willing and able to sign a study specific consent and comply with the requirements of the protocol including follow up visits and imaging.

You may not qualify if:

• levels requiring surgical intervention
• Non-degenerative pathology including tumor, trauma, post-laminectomy kyphosis
• Psudeoarthrosis at the index level
• Previous fusion at the levels to be treated or at adjacent level
• Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis.
• History of osteoporotic fracture
• History of an endocrine or metabolic disorder known to affect bone and mineral metabolism
• Inadequate tissue coverage over the operative site or taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• Known allergy to titanium or cobalt chrome or may be sensitive to materials
• Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
• Lumbar kyphosis- lumbar lordosis \< 20°
• Degenerative scoliosis \>20° OR any other pathology scoliosis (idiopathic, congenital, posttraumatic, iatrogenic)
• Active systemic infection or infection at the operative site
• Marked local inflammation
• Any open wounds

Sponsors & Collaborators

• Bone and Joint Clinic of Baton Rouge: lead

MeSH Terms

Conditions

Intervertebral disc disease

Results Point of Contact

• Title: Research Projects Director
• Organization: Bone and Joint Clinic of Baton Rouge

aobrien@bjcbr.com

2254218207

Study Officials

• Chambliss Harrod, MD

  Bone and Joint Clinic of Baton Rouge

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08