Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- CONDUIT Porous Titanium Spinal Cage
- 疾病 / 适应症
- Spinal Fusion
- 发起方
- Francis Farhadi
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Brantigan-Steffee-Frasier (BSF) Fusion Scale
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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:
- Porous titanium cages
- Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
详细描述
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.
研究者
Francis Farhadi
Associate Professor, Neurosurgery
University of Kentucky
入排标准
入选标准
- •Patients will be considered for inclusion if:
- •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.
- •They are over the age of 18 years old.
- •They have been unresponsive to conservative care for a minimum of 6 months.
- •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.
排除标准
- •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:
- •They have had previous lumbar arthrodesis surgery.
- •They require additional bone grafting materials other than local autograft bone.
- •There is inadequate tissue coverage over the operative site.
- •There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
- •Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
- •Subject has an active local or systemic infection.
- •Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
- •Subject is morbidly obese, defined as a body mass index (BMI) greater than
- •Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
研究组 & 干预措施
CONDUIT Porous Titanium Spinal Cage
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.
干预措施: CONDUIT Porous Titanium Spinal Cage
PROTI 360 Titanium-Coated PEEK Spinal Cage
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.
干预措施: PROTI 360 Titanium-Coated PEEK Spinal Cage
结局指标
主要结局
Brantigan-Steffee-Frasier (BSF) Fusion Scale
时间窗: Six months following procedure
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)
次要结局
- Oswestry Disability Index (ODIv2.1a)(Preoperative, three, six, twelve, and twenty-four month follow-ups.)
- PROMIS-10 Global(Preoperative, three, six, twelve, and twenty-four month follow-ups.)
- Neurological Pain Scale for Back and Legs(Preoperative, three, six, twelve, and twenty-four month follow-ups.)