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Spinal Fusion Device

Titanium vs. PEEK Devices for Spinal Fusion (TLIF Trial)

Phase 4

Waitlist Available

Research Sponsored by Twin Cities Spine Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post-op

Awards & highlights

TLIF Trial Summary

This trial looks at how different materials used in surgery affect patients' recovery over two years.

Who is the study for?

This trial is for adults aged 18-70 who need a single-level spinal fusion (TLIF) to treat lumbar stenosis and spondylolisthesis, after not improving with at least 6 weeks of non-surgical care. It's not open to those who've had previous lumbar fusions, are pregnant, or need surgery due to infection, tumors, or trauma.Check my eligibility

What is being tested?

The study compares two types of spacers used in spinal fusion surgery: one made of titanium and the other made from PEEK material. Patients will be randomly assigned to receive either device and monitored for clinical and radiographic outcomes up to 24 months post-surgery.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with spinal fusion devices may include pain at the graft site, nerve damage, blood clots, graft movement or failure leading to additional surgeries.

TLIF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fusion Status of 1 level Lumbar TLIF

Revision Surgeries

Secondary outcome measures

Patient Reported Outcome Measures

TLIF Trial Design

2Treatment groups

Experimental Treatment

Group I: TitaniumExperimental Treatment1 Intervention

Medtronic Adaptix

Group II: PEEKExperimental Treatment1 Intervention

Medtronic Capstone

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Twin Cities Spine CenterLead Sponsor

2 Previous Clinical Trials

206 Total Patients Enrolled

Media Library

PEEK Fusion Device (Spinal Fusion Device) Clinical Trial Eligibility Overview. Trial Name: NCT05691062 — Phase 4

Spinal Fusion Research Study Groups: Titanium, PEEK

Spinal Fusion Clinical Trial 2023: PEEK Fusion Device Highlights & Side Effects. Trial Name: NCT05691062 — Phase 4

PEEK Fusion Device (Spinal Fusion Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05691062 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to geriatric patients?

"Patients who are between the ages of 18 and 70 can sign up to participate in this clinical trial."

Answered by AI

Has Polyether Ether Ketone been granted clearance from the Food and Drug Administration?

"There is a wealth of evidence supporting the safety profile of PEEK, resulting in it being given a score of 3 on our scale. This is because this particular medication has been approved by regulatory bodies."

Answered by AI

Are there any slots remaining for volunteers to join this clinical trial?

"Per clinicaltrials.gov, this investigation is not recruiting new participants at present, but was initially published on 11th January 2023 and last amended 18th of the same month. Despite no longer actively enrolling individuals, there are 61 other trials currently accepting applicants."

Answered by AI

What criteria must a person fulfill to be eligible for this clinical trial?

"This lumbar stenosis and spondylolisthesis study is recruiting up to 80 candidates, aged between 18-70, who have not responded favourably to non-operative treatments. The inclusion criteria for the trial stipulate that participants must be undergoing 1 level TLIF surgery."

Answered by AI

Recent research and studies

European Spine JournalJournal

Comparison of Fusion Rates Following Transforaminal Lumbar Interbody Fusion Using Polyetheretherketone Cages or Titanium Cages with Transpedicular Instrumentation

Nemoto, Osamu, Takashi Asazuma, Yoshiyuki Yato, Hideaki Imabayashi, Hiroki Yasuoka, and Akira Fujikawa. 2014. “Comparison of Fusion Rates Following Transforaminal Lumbar Interbody Fusion Using Polyetheretherketone Cages or Titanium Cages with Transpedicular Instrumentation”. European Spine Journal. Springer Science and Business Media LLC. doi:10.1007/s00586-014-3466-9.

clinicaltrials.govStudy

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Bayard Carlson 2023. "Titanium vs. PEEK Fusion Devices in 1 Level TLIF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05691062.