Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
This single-center randomized controlled trial will prospectively evaluate the safety and efficacy of porous titanium cages supplemented with a pedicle screw system as compared to titanium-coated PEEK cages currently used in routine fashion for lumbar interbody fusion procedures.
These cages are FDA approved and the study is designed to compare the outcomes of subjects receiving either implant. This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized).
This study will enroll a maximum of 108 subjects (approximately n = 54 per group), with subjects followed for a minimum of 12 months post-surgery. A total cage sample size of 108 cages (n = 54 cages per group) was calculated with a power of 80% (alpha =0.05) and based on the assumption that 55% of cages in the titanium-coated PEEK group would achieve a solid fusion by 6 months, as compared to 80% in the porous titanium group. Up to two cages may be placed in a single subject. Therefore, it is possible that the maximum number of human subjects would be 54 if all are multi-level procedures. Since there are always mixtures of single and multi-level procedures, the actual number of subjects will be closer to 80, with a maximum ceiling of 108.
These assumptions are based on prior imaging findings in patients undergoing TLIF procedures using these cages. An interim analysis is planned once, at minimum, half of the cage accrual is met. In the case early findings show a statistical difference in the primary outcome between the two cages, enrollment will be allowed to cease as investigators are unlikely to maintain clinical equipoise to continue randomizing patients. Conversely, if the interim analysis suggests that statistical significance is unlikely, the investigators will be allowed to choose to close the trial early for futility.
Randomization will occur in 4 and 6 subject blocks to ensure comparability and enhance blinding for this sample size. Subjects will be further stratified for smoking due to the significant risk it places on successful fusion outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONDUIT Porous Titanium Spinal Cage | Active Comparator | Solid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability. |
|
| PROTI 360 Titanium-Coated PEEK Spinal Cage | Active Comparator | Spinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONDUIT Porous Titanium Spinal Cage | Device | Already included in arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Neurological Pain Scale for Back and Legs |
Not provided
Inclusion Criteria:
Patients will be considered for inclusion if:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francis Farhadi, MD, PhD | University of Kentucky | Principal Investigator |
| Craig van Horne, MD, PhD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000844 | Ankylosis |
| D013168 | Spondylolisthesis |
| D011542 | Pseudarthrosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
Not provided
Not provided
Two types of spinal cages will be evaluated against one another for patient outcomes. It is possible that a single patient may receive both cages, but outcomes will be radiographically assessed individually by cage.
Not provided
Not provided
Double-Blinded
| PROTI 360 Titanium-Coated PEEK Spinal Cage | Device | Already included in arm/group descriptions. |
|
|
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. |
| 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. |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D005599 | Fractures, Ununited |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |