top of page
Lab Attendent

Clinical Evidence

Quality scientific research proves what works

KIC
VENTURES

Research

15+ years of proof

A prolific body of proven clinical outcomes and biomechanical data from the KIC technology portfolio developed through decades of research with expert physicians.

Biomechanical
Evidence

FacetFuse biomechanical set up.png

AxioMed Viscoelastic Disc Replacement

Investigational Device Exemption (IDE) Lumbar Clinical Trial 

Freedom Lumbar Disc (FLD) One-Level IDE Pivotal Study in the Treatment of Lumbar Degenerative Disc Disease completed in 2015

The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This was a prospective, multi-center, randomized, controlled trial. 300 patients with DDD was randomized to disc arthroplasty with the FLD device or the ProDisc (control device). The overall purpose (objective) of this trial was to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.

AxioMed Studies

AxioMed cervical 02.jpg

Kingsley R. Chin^, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle

The Freedom Cervical Disc (FCD) performs as expected in patients with single-level and two-level degenerative disc disease.  In this early clinical experience with the FCD, patients experienced similar pain relief and lower disability at 2 years follow-up compared to both articulating and viscoelastic TDRs

Burkhard Rischke, MD, PhD, Raymond S. Ross, MD, Boris A. Jollenbeck, MD,  Kari B. Zimmers, BS*, Neal D. Defibaugh, BS

The VTDR is intended to restore healthy anatomic properties and stability characteristics to the spinal segment.  This  study is the first to evaluate a VTDR in a 50-patient, multicenter European study

Burkhard Rischke, MD, PhD, Kari B. Zimmers, BS, Eric Smith, BS

Significantly higher back and leg pain relief were observed after viscoelastic total disc replacement in comparison with anterior lumbar interbody fusion. 

Edward C. Benzel, Isador H. Lieberman, E. Raymond Ross, Raymond J. Linovitz, James Kuras, Kari Zimmers

The one-piece VTDR evaluated in this biomechanical study, replicating the ROM, flexibility, and stiffness of a natural lumbar disc, represents the next-generation lumbar TDR and promises over 50 years of durability.

NanoFuse Biologics Research

Featured Study

Nanofuse Unique Combination of Synthetic Bioactive Glass plus DBM in Cervical Spine Fusion  

Kingsley R. Chin^, Erik Spayde, William M. Costigan, Vito Lore, Chukwunonso Ilogu , Jason A Seale

Our study demonstrated 100% fusion rate.  VAS neck and NDI outcomes improved by 89% and 68% respectively with the use of combination biologic. Signs of fusion were seen as early as 6 weeks with anterior bridging bone

NanoFuse Studies

James F. Kirk*, Gregg Ritter, Chad Waters, Sonoko Narisawa, José Luis Millán, and James D. Talton

NanoFuse DBM showing superior bone growth results over DBM alone

James F. Kirk, Gregg Ritter, Michael J. Larson, Robert C. Waters, Isaac finger, John Waters, John H. Abernethy, Dhyana Sankar, James D. Talton, Ronald R. Cobb

Fusion for NanoFuse alone was 61% while no fusion observed in the sham or NovaBone Putty groups at 24 weeks

Mohamed N. Rahamana,*, Delbert E. Daya, B. Sonny Balb, Qiang Fuc, Steven B. Junga,d, Lynda F. Bonewalde, Antoni P. Tomsia

Bioactive glass has also been shown to enhance neocartilage formation during in vitro culture of chondrocyte-seeded hydrogels, and to serve as a subchondral substrate for tissue-engineered osteochondral constructs

InSpan Research

Featured Study

Prospective 5-year L5-S1 and L4-5 Studies

image.png

InSpan Slim

01

Prospective 5-year follow-up of L5–S1 versus L4–5 midline decompression and interspinous-interlaminar fixation as a stand-alone treatment for spinal stenosis compared with laminectomies

Kingsley R. Chin^, Jason A. Seale, Erik Spayde, William M. Costigan, Nishant Gohel,  Daniel Aloise, Vito Lore.

Spinal stenosis patients treated with midline decompression and InSpan IFD, used as a stand-alone treatment for interspinous-interlaminar fixation, at L4–5 and L5–S1, showed improved outcome scores and low complication and revision rates at five years and were comparable to historical open laminectomy data. 

InSpan Vega

02

inspan L4-5 ap and lateral (1).jpg

Kingsley R. Chin^, Fabio J. R. Pencle, Amala Benny, Jason A. Seale

Long term results demonstrated improved outcomes in patients who underwent Interspinous distraction decompression in an ambulatory surgery center using the INSPAN IPD at L4−L5 for Degenerative Spinal Stenosis. There was one revision converted to hemilaminectomy. There were no complications or blood transfusions

InSpan Studies

inspan raikar.jpg

Soubrata V. Raikar  , Arun A. Patil  , Deepak K. Pandey  , Sidharta R. Kumar 

InSpan works both as a distractor and internal decompressor of the spinal canal. It is simple to use and safe. Statistically significant improvement was reported at a median follow-up of 19 months

Biomechanical Study of InSpan Dual-Locking Set Screw Symmetrical Design versus Aspen Single-Locking Asymmetric Control

*

The dual-locking symmetrical InSpan IFD demonstrated superior fixation strength in both static disassembly and pullout bench tests compared to the Aspen IFD

image.png

Stabilizing Grade 2 Degenerative Spondylolisthesis With Interspinous interlaminar fixation device

*

This study demonstrate successful InSpan interspinous lumbar fusion for grade 2 degenerative spondylolisthesis.  

Sacrix Research

Featured Study

Case Series of Sacrix Salvaging SI-Bone

image.png
sacrix revision of si bone.jpg

Kingsley R. Chin^, Richard R. Francis, William M. Costigan, Erik Spayde, Chidubem Ike,  Yujin Jeong, Deepak K. Pandey, Jason A. Seale.

This is a clinically valuable report because until now there was no reconstructive surgery to revise direct lateral implants other than removal with potential neurovascular risks. This is the first article to demonstrate a lateral-oblique transfixation technique with two variable-threaded screws for successful salvage of SIJ pseudoarthrosis after direct lateral fixation without implant removal. The Sacrix technique achieved immediate stability and long-term fusion documented on computed tomography (CT) scan as early as  6 months.

Sacrix Studies

sacrix ct.jpg

Kingsley R. Chin, Fabio J. Pencle, Jason A. Seale, Deepak K. Pandey

This pilot study demonstrated the feasibility and effectiveness of a new percutaneous lateral-oblique SIJ fusion technique with a threaded compression screw done safely in an ASC. Patients demonstrated early pain relief and long-term fusion of their SIJ. 

sacrix mario.jpg

Mario Cahueque, MD*, Javier Grajeda, Javier Ardebol, MD, Enrique Azmitia, MD.

Compared to the lateral technique group, patients undergoing Sacrix MIS SIJ fusion through the posterior oblique technique experienced greater pain relief and demonstrated a trend toward better functional improvement, with shorter operative times and duration of hospital stay. 

image.png

Soubrata V. Raikar, Thomas Nilles-Melchert, Arun A. Patil, Walter Crum, Deepak Pandey

Posterior oblique approach for SIJ fusion is a minimally invasive procedure that proved to be effective and safe in this series. It also resulted in solid radiographic fusion, decreased pain, and improved function

FacetFuse Research

Featured Study

Transfacet Pedicle screws vs Pedicle Screws: Cadaveric Biomechanical Studies

image.png
facetfuse transfacet pedicle screw 3d.jpg

Kingsley R. Chin, MD*,Marco T. Reis, MDc, Phillip M. Reyes, BSE, Anna G.U. Newcomb, MS, Anda Neagoe, BS, Josue P. Gabriel, MD, Roger D.Sung, MD, Neil R.Crawford, PhD.

These results suggest that fixation at L4–L5 with TFPS is a promising alternative to PSR, with or without TLIF.  A TLIF device was less stable than the native disc with both methods of instrumentation presumably because of a fulcrum effect from a relatively small footplate. Additional interbody support may be considered for improved biomechanics with TLIF

FacetFuse Studies

biomechanical tfps vs psr_edited.jpg

Kingsley R. Chin*, Anna G. U. Newcomb, Marco T. Reis, Phillip M. Reyes, Grace A. Hickam, Josue Gabriel, Fabio J.R. Pencle, Roger D. Sung, Neil R.Crawford.

Posterior fixation with transfacet pedicle screws provides equivalent immediate stability to similarly sized pedicle screws.  However, in the presence of a lateral interbody fusion device, pedicle screws seem to resist loosening more and may be a better option for fusion in the upper lumbar spine

facetfuse transfacet pedicle screw2.jpg

Kingsley R. Chin, MD,* Jason Seale, MBBS*, Vanessa Cumming ,MBBS

Transfacet pedicle screws were successfully placed in 2 patients in a stepwise technique described to achieve lumbar fusion

A Comparative Cadaveric Biomechanical Study of Bilateral FacetFuse Transfacet Pedicle Screws (TFPS) versus Unilateral or Bilateral Standard Pedicle Screws-Rod (PSR)

*

Bilateral FacetFuse® TFPS demonstrated superior immediate stability than unilateral PSR and was an equivalent substitute to bilateral PSR constructs at the L5-S1 native disc level

biomechanical tfps vs psr2.jpg

Lisa A.  Ferrara, MS, Jessica L. Secor, BS, Byung-ho Jin, MD, Andrew Wakefield, MD, Serkan Inceoglu, MS, Edward C. Benzel, MD

In this biomechanical study, transfacet pedicle screw fixation appears equivalent to traditional pedicle screw fixation.

LESS Retractors

Featured Study

LES-Tri Retractor For Lumbar Microdiscectomy

image.png
image.png

Kingsley R. Chin, MD*, Fabio J R Pencle MBBS, Jason A Seale MBBS, Frank K Pencle MBBS.

This less exposure surgery technique can be performed to allow lumbar decompression, with or without microdiscectomy. This is an anatomy preserving technique with improved outcomes

bottom of page