Independent evidence behind the StabiLink Interlaminar Fixation System.
Interlaminar fixation and fusion (ILFF) has emerged as a safe and effective alternative to traditional pedicle screw fusion (PSF) techniques in the treatment of lumbar spine pathology. Unlike PSF, which requires exposure of pedicles and careful navigation near neural structures, ILFF leverages the thicker and stronger cortical bone at the laminar junction to achieve rigid fixation and fusion while avoiding the spinal canal. Minimally invasive ILFF techniques offer several intraoperative advantages, including reduced blood loss, shorter operative times, and smaller incisions compared to PSF procedures. While improved patient-reported outcomes — such as reductions in Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) pain scores — are crucial measures of clinical success, radiographic confirmation of fusion remains essential to satisfy long-term biomechanical integrity and payer requirements, including those of Medicare. The purpose of this clinical case series is to assess the capability of the StabiLink Interlaminar Fixation System to achieve a solid interlaminar fusion as verified by computed tomography (CT) imaging.
This study retrospectively evaluated postoperative CT scans of patients who underwent lumbar interlaminar fixation and fusion utilizing the StabiLink system. All CT assessments were conducted by an independent board-certified radiologist blinded to patient identifiers and clinical outcomes.
A total of 21 patients were included. Inclusion criteria encompassed adults undergoing posterior lumbar fusion with interlaminar fixation as either a stand-alone procedure or as an adjunct to interbody fusion. Exclusion criteria included prior instrumentation at the index level or incomplete imaging follow-up.
| Variable | Value |
|---|---|
| Number of Patients | 21 |
| Male | 11 |
| Female | 10 |
| Age Range (yrs) | 38–89 |
A total of CT images obtained between 10 and 16 months postoperatively were used to evaluate fusion status. Fusion grading was defined as: Solid Fusion — continuous trabecular bone bridging the interlaminar space; Partial Fusion — incomplete or unilateral bridging; No Fusion — absence of bone continuity across the fusion site.
| Follow-up (months) | Fusion Category | Percentage |
|---|---|---|
| 10–16 (mean: 12) | Solid | 89% |
| 10–16 (mean: 12) | Partial | 11% |
| 10–16 (mean: 12) | None | 0% |
At an average follow-up of 12 months postoperatively, 89% of patients demonstrated solid fusion, while 11% exhibited partial fusion. There were no cases of non-fusion or device-related complications noted on CT imaging.
The findings from this case series support that interlaminar fixation with the StabiLink System achieves high rates of solid fusion when assessed by CT. The 89% solid fusion rate is comparable to, or exceeds, fusion rates typically reported for pedicle screw-based constructs in similar patient populations. The minimally invasive approach of ILFF not only reduces surgical morbidity but also avoids potential risks associated with pedicle screw trajectories near neural structures. The laminar fixation mechanism, which utilizes cortical bone purchase, provides a strong posterior tension band that promotes stability and bone fusion. Although this study is limited by its sample size and retrospective nature, the results underscore the clinical potential of the StabiLink system as a reliable, less invasive solution for achieving spinal fusion in appropriately selected patients.
CT-based evaluation confirms that the StabiLink Interlaminar Fixation System achieves a high rate of solid lumbar fusion. This system represents a minimally invasive, biomechanically sound, and radiographically effective alternative to traditional pedicle screw fusion techniques.
A validated explicit finite element (FE) model of the L4-L5 Functional Spine Unit was constructed from a series of CT images using ScanIP (Simpleware, Exeter, UK). The model was scaled (size only) to provide an appropriate size for the selected fixation devices.
StabiLink® and an idealized pedicle screw construct with 5mm rods were virtually implanted in the L4-L5 FSU model.
Six loading conditions were simulated for each implanted model (StabiLink®, pedicle screws/rods, and the natural Functional Spine Unit). Each loading condition applied a pure moment of 10 N/m in flexion, extension, lateral bending (left and right), or axial rotation (clockwise and counterclockwise).
The StabiLink® construct provided significant fixation of the L4-L5 FSU compared to the gold-standard pedicle screw construct. Differences between the StabiLink® construct and the pedicle screw construct are predicted to be relatively small in this model in the critical areas of lateral bending and axial rotation.
Although the use of cadaveric specimens has the advantage of using actual tissue, it has several disadvantages, including significant variability of tissue supporting the implant, as well as difficulty measuring disc pressure, bone strain, and facet joint contact pressure. The validated finite element (FE) model presented in this study effectively addresses the disadvantages of cadaveric testing.
The novel interlaminar design of the StabiLink device has been shown to limit motion in all three planes in a way that has not been reported by legacy interspinous devices.
*OrthoAnalysts, LLC. Analysis of Lumbar Fixation Constructs, February 2016. Data on file, Southern Spine, LLC.
The StabiLink® MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1–S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use. Designed to be used with bone graft material.
The safety and effectiveness of spinal fixation systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. The safety and effectiveness of these devices for any other conditions are unknown. A successful result is not always achieved in every surgical case.
Contraindications include, but are not limited to: allergy to titanium or foreign body sensitivity; known or suspected infection; severe osteoporosis or other conditions affecting bone remodeling; morbid obesity; pregnancy; incompetent or missing posterior arch (e.g., laminectomy, pars defect); among others.
Possible complications specific to the device may include early or late implant bending, breakage, failure, loosening, movement, or migration; bone and/or spinous process fracture; allergic reaction to implant material.
The StabiLink® device has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment.
For complete indications, contraindications, warnings, precautions, and directions for use, please refer to the StabiLink® Instructions for Use (IFU).
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
