Efficacy of Platelet-rich Plasma Impregnation for Unidirectional Porous Β-tricalcium Phosphate in Lateral Lumbar Interbody Fusion: Study Protocol for a Randomized Controlled Trial

Abstract BackgroundPlatelet-rich plasma has been increasingly used in spinal fusion surgery. However, the efficacy of platelet-rich plasma in lateral lumbar interbody fusion is unclear. In Japan, Affinos® (Kuraray Co., Tokyo, Japan), which is a β-tricalcium phosphate artificial bone, has been increasingly used for spinal fusion as a bone graft. The purpose of this trial is to demonstrate whether Affinos® impregnated with platelet-rich plasma can achieve a higher fusion rate, more rapid fusion, and better clinical outcomes than Affinos® alone.Methods/DesignThe current study is a prospective randomized controlled trial. The current trial will include consecutive patients scheduled for lateral lumbar interbody fusion. Since an intervertebral cage for lateral lumbar interbody fusion has two spaces for a bone graft, two bone grafts are inserted for each intervertebral level. In the current study, an artificial bone with plate-rich plasma will be inserted into one space and an artificial bone without platelet-rich plasma will be inserted into the other space. We will compare the fusion rates between the bone graft with and without platelet-rich plasma. Our primary endpoint will be the interbody fusion rate at 1 year after surgery. DiscussionThe current trial will verify the efficacy of platelet-rich plasma with Affinos® for bony fusion in lateral lumbar interbody fusion. This trial will provide substantial evidence for the effectiveness and safety of platelet-rich plasma in spinal fusion surgery.Trial registrationJapan Registry of Clinical Trials (jRCT), ID: jRCTb032200199. First registered on 13 November 2020, https://jrct.niph.go.jp/latest-detail/jRCTb032200199. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

Download Full-text

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

Global Spine Journal ◽

10.1177/2192568220985472 ◽

2021 ◽

pp. 219256822098547

Author(s):

R. F. M. R. Kersten ◽

F. C. Öner ◽

M. P. Arts ◽

M. Mitroiu ◽

K. C. B. Roes ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Silicon Nitride ◽

Interbody Fusion ◽

Controlled Trial ◽

Segmental Motion ◽

Lumbar Interbody Fusion ◽

Double Blind ◽

Randomized Controlled ◽

Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

Download Full-text