Spondylolisthesis Clinical Trial
Official title:
Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial
NCT number | NCT05583864 |
Other study ID # | 77018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2022 |
Est. completion date | May 2026 |
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | May 2026 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: Patients will be considered for inclusion if: 1. They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system. 2. They are over the age of 18 years old. 3. They have been unresponsive to conservative care for a minimum of 6 months. 4. They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. Exclusion Criteria: Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if: 1. They have had previous lumbar arthrodesis surgery. 2. They require additional bone grafting materials other than local autograft bone. 3. There is inadequate tissue coverage over the operative site. 4. There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis. 5. Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.). 6. Subject has an active local or systemic infection. 7. Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted). 8. Subject is morbidly obese, defined as a body mass index (BMI) greater than 40. 9. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 10. Subject is currently involved in another investigational drug or device study that could confound study data. 11. There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. 12. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care. 13. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams. 14. Subject is a prisoner. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Kentucky |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brantigan-Steffee-Frasier (BSF) Fusion Scale | Graded radiographic evaluation of ossification and/or pseudarthrosis between vertebrae. The evaluation applies a three-level scale of fusion success:
BSF-1: Radiographical pseudarthrosis BSF-2: Radiographical locked pseudarthrosis BSF-3: Radiographical fusion Radiographic Success: Radiographic success is defined by radiographical fusion (BSF-3) presenting bone bridges within at least half of the fusion area with at least the density originally achieved at surgery. Radiographic Failure: Radiographic failure is defined by radiographical pseudarthrosis (BSF-1 or -2) |
Six months following procedure | |
Secondary | Oswestry Disability Index (ODIv2.1a) | Subject self-assessment survey pertaining to quality-of-life and pain measures. Scale ranges from 0-100%. The higher the percentage, the lower the quality of life and the greater the pain. | Preoperative, three, six, twelve, and twenty-four month follow-ups. | |
Secondary | Neurological Pain Scale for Back and Legs | Subject self-assessment survey pertaining to pain presence in legs and back. The scale runs from 0-10, with 0 indicating no pain and 10 the worst pain possible. | Preoperative, three, six, twelve, and twenty-four month follow-ups. | |
Secondary | PROMIS-10 Global | Patient reported survey to rate quality-of-life and pain experience throughout life of study. Initially gives a raw score for both physical and mental well-being between 4 and 20, which is converted into a T-score between 16.2 and 67.7. The T-score is directly correlated with what is being evaluated. In other words, the higher the T-score, the higher the quality of life and the lower the pain. | Preoperative, three, six, twelve, and twenty-four month follow-ups. |
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