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Scientific Articles   |    
Evaluation of the Safety of a Novel Knee Load-Bypassing Device in a Sheep Model
Matthew J. Allen, VetMB, PhD1; Katy L. Townsend, BVSc1; Thomas W. Bauer, MD, PhD2; Stefan M. Gabriel, PhD3; Mary O'Connell, PhD3; Anton Clifford, PhD3
1 Department of Veterinary Clinical Sciences, The Ohio State University College of Veterinary Medicine, 601 Vernon L. Tharp Street, Columbus, OH 43210. E-mail address for M.J. Allen: allen.1243@osu.edu
2 Departments of Pathology, Orthopaedic Surgery, and The Spine Center, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195
3 Moximed, Inc., 26460 Corporate Avenue, Suite 100, Hayward, CA 94545
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  • Disclosure statement for author(s): PDF

Investigation performed at The Ohio State University, Columbus, Ohio



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jan 04;94(1):77-84. doi: 10.2106/JBJS.J.00918
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Abstract

Background: 

Unloading treatments for osteoarthritis of the knee, such as valgus braces, have been shown to reduce medial joint-loading and pain. The purpose of this preclinical study was to investigate the tissue response to an extracapsular implantable device (KineSpring System; Moximed, Hayward, California) that is designed to reduce loading across the medial compartment of the knee.

Methods: 

Eleven sheep were implanted with the KineSpring System, consisting of bases secured to the medial femoral and tibial cortices with bone screws and also consisting of a joint-spanning load-absorber composed of a piston and spring assembly inside a polymeric sheath. In nine sheep, titanium alloy washers with either an uncoated or a plasma-sprayed titanium-hydroxyapatite (TPS-HA) coated undersurface were fixed with screws to the contralateral femur and tibia to investigate the effects of surface treatment on extracortical bone apposition. The functionality of the KineSpring System was assessed by fluoroscopy, tissue response was determined by gross and microscopic histology, and implant fixation was determined by radiography, microradiography, and histomorphometry at four, twelve, twenty-six, and fifty-two weeks.

Results: 

The function of the KineSpring System was confirmed in all sheep. Seventeen of eighteen TPS-HA coated bases and thirty-six of thirty-six washers had stable bone fixation; one coated base was loose with evidence of infection. At four weeks, there was an early, expected inflammatory response, but this response resolved by twelve weeks and a pseudosynovial membrane formed around the sheath. Bone apposition increased over time for the TPS-HA coated bases and for uncoated washers (p < 0.05). There was good apposition of the TPS-HA coated washers even at early time points, with no subsequent increase in apposition over time.

Conclusions: 

The KineSpring System demonstrated safety in a simulated use model for periods of up to fifty-two weeks. Screws result in stable implant fixation and TPS-HA coating allows for early and long-lasting cortical bone apposition and integration.

Clinical Relevance: 

This implant warrants further investigation as a means of reducing medial compartment loading and pain in patients with osteoarthritis of the knee.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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