Publication Date: September 6, 2023
Patient-Reported Outcomes and Computed Tomography Review After Minimally Invasive Fusion of the Sacroiliac Joint With Aggressive Joint Decortication and Joint Compression
William W. Cross III, MD; Marko N. Tomov, MD; Michelle Y. Hung, PA-C, MS; Jeffrey M. Muir, MSc, DC, MSc (Clin Epi)
The sacroiliac joint (SIJ) is a common, underrecognized source of low back pain. This study evaluated outcomes in patients undergoing sacroiliac joint fusion (SIJF) using a novel, minimally invasive SIJF system emphasizing compressive forces across an aggressively debrided SIJ. In this study, data was reviewed from a continuous set of patients presenting to a large, tertiary care hospital from September 2017 to August 2019.
The benefits of this approach are evident in our rates of radiographic fusion, with independent radiographic review revealing at least partial signs of radiographic fusion in 98% of joints and definitive bone bridging (grade 3 fusion) in 81% of joints at 12-month follow-up. Our study demonstrated that a SJIF system based on the principles of joint fusion - aggressive decortication, autogenous bone grafting, and joint compression - was associated with early and durable improvements in both radiographic fusion and patient-related outcomes. The results of this study support the growing body of evidence that SIJF surgery benefits patients with SIJ dysfunction.
Publication Date: October 18, 2019
Biomechanical comparison of bone-screw-fasteners versus traditional locked screws in plating female geriatric bone
Malcolm R DeBaun , Steven T Swinford, Michael J Chen, Timothy Thio, Anthony A Behn, Justin F Lucas, Julius A Bishop, Michael J Gardner
To biomechanically compare plated constructs using nonlocking bone-screw-fasteners with interlocking threads verses locking screws with traditional buttress threads in geriatric female bone.
In female geriatric bone, constructs fixed with bone-screw-fasteners incorporate multiplanar interlocking thread geometry and performed similarly to traditional locked plating.
Journal: International Journal of Spine Surgery
Publication Date: October 15, 2018
In Vitro Biomechanical Evaluation of a Novel, Minimally Invasive, Sacroiliac Joint Fixation Device
William W. Cross III, MD, Sigurd H. Bergen, MD, Nick Slater, MS, Jennifer N. Lehrman, MS, Anna G. U. S. Newcomb, MS, and Brian P. Kelly, PHD
Sacroiliac (SI) joint pathology may result in low-back pain, which causes substantial disability. Treatment failure with operative management of SI pain may be related to incomplete fusion of the joint and to fixation failure. The objective of this study was to evaluate the initial biomechanical stability of SI joint fixation with a novel implantable device in an in vitro human cadaveric model.
Instrumentation with the SI screw fixation device significantly reduced mean joint ROM compared to the destabilized condition, with similar ROM in flexion-extension and axial rotation, and it significantly reduced ROM in lateral bending compared to that for the intact joint. The ROM values observed with the instrumented condition were comparable to levels of mobility considered favorable for spinal fusion.
Journal: Journal of Orthopedic Trauma
Publication Date: April 2019
A New Fastener With Improved Bone-To-Implant Interface Shows Superior Torque Stripping Resistance Compared With the Standard Buttress Screw
Nicholas A Alfonso, Todd Baldini, Philip F Stahel
The conventional AO buttress screw used for fracture fixation relies on a historic buttress thread design, which is prone to stripping at the bone–implant interface. We hypothesized that a new Bone-Screw-Fastener with an innovative interlocking thread design demonstrates increased resistance to torque stripping forces compared with the buttress screw, without compromising pullout strength.
These data demonstrate the superiority of the new Bone-Screw-Fastener over the conventional AO buttress screw regarding protection from torque stripping forces. In addition, the new thread design that interlocks to the bone does not sacrifice axial pullout resistance conveyed by the buttress screw. Future controlled trials will have to validate the in vivo relevance of these findings in a clinical setting.
Journal: Patient Safety in Surgery
Publication Date: March 20, 2017
Introducing the "Bone-Screw-Fastener" for improved screw fixation in orthopedic surgery: A revolutionary paradigm shift?
Philip F Stahel, Nicholas A Alfonso, Corey Henderson, Todd Baldini
We hypothesize that the new Bone-Screw-Fastener overcomes the classic shortcomings of conventional orthopedic screws with buttress threads by ease of insertion, improved bone preservation, increased resistance to off-axis multidirectional loading forces and to stripping of the threads. These advanced biomechanical and biological properties can potentially mitigate the classic limitations of conventional buttress screws by providing better resistance to implant failure under physiological loads, preserving bone biology, and thus potentially improving patient outcomes in the future.
Implications of Hypothesis
Once validated in multicenter RCTs, the new Bone-Screw-Fastener may drive a change in paradigm with regard to its innovative biomechanical principles and biologic bone preservation for surgical applications requiring screw fixation.
Journal: International Journal of Spine Surgery
Publication Date: August 23, 2016
Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction
David W. Polly, MD, John Swofford, MD, Peter G. Whang, MD, Clay J. Frank, MD, John A. Glaser, MD, Robert P. Limoni, MD, Daniel J. Cher, MD, Kathryn D. Wine, MPH, Jonathan N. Sembrano, MD, and the INSITE Study Group
To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction.
In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months.
This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation.
Journal: The Open Orthopedics Journal
Publication Date: December 29, 2017
Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System
William W Cross, Arnold Delbridge, Donald Hales and Louis C Fielding
Sacroiliac joint (SIJ) degeneration is a common source of low back pain (LBP). Minimally invasive (MI) SIJ fusion procedures have demonstrated meaningful clinical improvement. A recently developed MI SIJ fusion system incorporates decortication, placement of bone graft and fixation with threaded implants (DC/BG/TF).
The patients in this series demonstrated significant improvement in LBP. Fusion rates at 24 months demonstrate promise for this system, which utilizes the established orthopedic principles of DC/BG/TF to achieve arthrodesis. Further study is warranted to demonstrate comparative fusion rates for different implant systems.
Journal: Frontiers in Veterinary Science
Publication Date: June 29, 2023
Ex Vivo Biomechanical Evaluation of a Bone-Screw-Fastener for Tibial Plateau Leveling Osteotomy
William S. Kettleman, Michael H. Jaffe, Robert W. Wills, Sara J. Dietz, and Steve H. Elder
The objective of this study was to investigate the effect of a novel screw type on stiffness and failure characteristics of a tibial plateau leveling osteotomy (TPLO) construct under cyclic loading conditions. The authors hypothesized that bone-screw-fasteners (BSF) would result in superior biomechanical stability compared with locking buttress screws (LBS).
The findings of this current study suggest that stabilization of the TPLO with bone-screw-fasteners provided no advantage to biomechanical stability under cyclic axial loading conditions when compared to the locking buttress screw. Bone-screw-fasteners may be an acceptable alternative to traditional locking screws for TPLO. Further research, particularly in vivo experiments, is warranted prior to clinical application.
Internal White Papers
Biomechanical Evaluation of Standard and Novel Sacroiliac Joint Fusion Bone-Implant Interfaces in a Sawbones Model
Quinten Kunz*, Justin Hyer*, Bridger Evans**, and Andrew Fauth, PhD*
*OsteoCentric Technologies, Inc., **NexTek Innovations, inc.
Integrity-SI® Fusion implants with standard bone-implant interfaces based on common buttress
threads and identical implants with a Mechanical Integration interface using UnifiMI were
biomechanically compared for maximum compression force, peak stripping torque, and cantilever bending/lever-out yield load in bone-foam blocks.
Integrity-SI Fusion Fastener implants with UnifiMI demonstrated significantly higher peak compression, peak stripping torque, and cantilever bending yield loads when tested in bone-foam constructs. These results demonstrate the marked improvement in biomechanical performance and stability that Mechanical Integration can provide an existing implant when converted to UnifiMI.