Dear JPO Editor-in-Chief,
I am writing with regard to the JPO article entitled, “Osteoarthritic Knee Braces on the Market: A Literature Review” by Ms Kelly S. Brooks, BS, CP, that was published in 2014. I was not aware of this article when it was first published, but I recently read and reviewed this study during an online AAOP (American Academy of Orthotists and Prosthetists) continuing education course that I took on December 29, 2016. I was surprised and disturbed to find that our patented and marketed custom-made osteoarthritis (OA) knee orthosis, commonly known and marketed as the V-Vas™, was not even mentioned in the article, despite of the author’s claim about having performed a thorough search for commercially available knee orthoses for treatment of OA.
The following are some of our concerns and positions relative to this article:
- The V-Vas custom knee orthosis is a US-manufactured/patented knee brace number 6,387,066 filed October 10, 2000.
- The V-Vas has been in use and marketed worldwide since the formation in 2002 of Tuscany Orthotic and Prosthetic Solutions Inc, an Ohio-based O&P design and manufacturing company.
- The V-Vas has been fitted to thousands of patients during that period, and some evidence-based references have been professionally published in the United Kingdom1–3 along with additional whitepapers, poster, podium, and workshop presentations at various national and state O&P meetings in the United States and other foreign countries.
- It was unfortunate that the author of this article failed to find any information on the V-Vas custom OA knee orthosis, considering it has been searchable on the Internet since 2002 (http://www.anatomicalconceptsinc.com/product/v-vas-orthosis/).
The Varum Valgum adjustable stress (V-Vas Orthosis) custom-made unloader knee orthosis is a new concept in treating patients who present with medial or lateral compartmental arthropathies. The custom design of the V-Vas incorporates several unique features that increase the effectiveness and compliance for the patient who is in need of an unloader orthosis. Instead of using a narrow frame like that on most all double and single upright designs, it uses a total contact cuff on the thigh and tibia along with a unique adjustable self-aligning polycentric joint system to create four points of pressure instead of three. With two points of pressure being applied as a counter force (located at the proximal and distal ends of the thigh and tibial cuffs on the affected side of the leg) and two points of pressure applied as the corrective force (located at the distal and proximal ends of the thigh and tibial cuffs respectively on the nonaffected side of the leg) to offload the affected compartment, there is no need for a condylar pad.4
As compared with the single upright design, the use of a counterforce strap is not necessary, once again, due to the four points of pressure used to create the bending offloading moment. This unique bending offloading moment is reproducible with each application and eliminates the subjectivity of a counterforce strap or condylar pad that is inherent in other designs. Its self-aligning polycentric hinge design features an efficient and effective means of linearly adjusting the varum or valgum angle (depending on which compartment is affected) without causing mechanical joint binding. This is a very patient- and practitioner-friendly design due to the mechanical joint allowing for nonmechanical-like bending of the knee and that never needs to be resquared. The V-Vas Orthosis has been very effective in the clinical management of patients with symptomatic medial compartment osteoarthritis. Other successful applications include lateral compartment osteoarthritis, abnormal genu valgum alignment with up to 30° of semiflexible deformity, nonoperative tibial plateau fractures, failed hardware or reconstruction of the tibial plateau, tibial plateau and/or femoral condyle spacers, and post total knee arthroplasty.4
The V-Vas Orthosis is currently available in a custom design. The finished design consists of a polypropylene-constructed posterior-opening thigh and tibial cuff that includes a corrugation to increase transverse plane integrity. The V-Vas Orthosis is secured to the limb via a Velcro popliteal strap, wrapped around the thigh and distal tibial cuff straps. The thigh and tibial cuffs are connected via a medial and lateral self-aligning polycentric knee joint. One of the self-aligning joints (placed on the affected side of the leg) has the ability to be lengthened linearly at its proximal and distal ends. The lengthening can be adjusted proportionally or disproportionately proximally (thigh) and/or distally (tibia) to accommodate varying proportions of soft tissue compression. This linear (lengthening) adjustment is achieved via a counterclockwise rotation of the adjustment screw. The opposing self-aligning polycentric joint in the V-Vas Orthosis design is static and functions as a fulcrum to the adjustable self-aligning polycentric joint.4
The ability to lengthen the upright in a linear motion allows for an anatomically correct varum or valgum bending offloading moment to be applied to the femur and tibia through the soft tissues via the thigh and tibial cuffs, respectively. The ability to lengthen the adjustable upright either proportionally or disproportionately is how the optimal bending offloading moment is achieved. The bending offloading moment when adjusted correctly will decelerate or stop the lateral or medial thrust that is associated with knee arthropathy instability. It is the bending offloading moment and the self-aligning joint capabilities that is unique only to the V-Vas Orthosis joint system, leading to improved compliance and pain reduction.4
I appreciate the opportunity to address the O&P profession in this forum. As a licensed orthotist with over 40 years' experience in the orthotics/prosthetics profession, I have devoted many years serving on ABC (American Board for Certification in Orthotics, Prosthetics & Pedorthics) and AOPA (American Orthotics & Prosthetics Association), and as a member/fellow of the Academy. My hope is that the information included within this letter will be given fair, professional consideration as additional educational information for my colleagues to review about the V-Vas, which is manufactured here in the United States at my place of business, Anatomical Concepts Inc.
About Anatomical Concepts Inc, USA
Since 1990, Anatomical Concepts has developed industry-leading medical devices: custom-fit and custom-fabricated orthoses for both upper and lower limbs. Anatomical Concepts Inc is the manufacturer and distributor of the V-Vas Knee Orthosis (KO) and Knee Ankle Foot Orthosis (KAFO). Anatomical Concepts is a team of practitioners, designers, and manufacturers utilizing advanced technology to develop superior products that not only deliver effective outcomes, but also present ease-of-use for the medical professional. The company is the original concept developer of the trademark PRAFO Orthosis, used in medical facilities internationally.
Anatomical Concepts is headquartered in Poland, OH, USA, and provides medical devices, services, and consulting both nationally and internationally. The company's innovative product line has inspired the procurement of 11 US product patents. Providing solutions for medical professionals and helping to improve patient outcomes is still the driving force behind the corporation. Anatomical Concepts Inc products are FDA registered and also carry the CE marking. All products are designed, manufactured, and trademarked by Anatomical Concepts Inc.
To learn more about Anatomical Concepts' range of products, learning resources, and events, please visithttp://www.anatomicalconceptsinc.comor call (800) 837–3888.
William W. DeToro, LO CO
CEO of Anatomical Concepts Inc and
Vice President of Tuscany Orthotic and
Prosthetics Solutions Inc
1. Munro WA, Buchan M, Jones D. Management of Severe OA of the Knee Using a V-Vas™ Customised Off-Loading Knee Orthosis. 13th World Congress of ISPO, Leipzig, Germany 10–15 2010. Available at: http://www.anatomicalconceptsinc.com/wp-content/uploads/2017/01/Case-Study-WAM-VVAS-POSTER-ISPO2-Small.pdf
2. Walkay S, Buchan M. Clinical Outcome Study of Knee Bracing in the Management of Osteoarthritis of the Knee: A Prospective and Retrospective Study. Orthopaed Proc: Bone Joint J Aug
2013;95-B(SUPP 31):59. Available at: http://www.anatomicalconceptsinc.com/wp-content/uploads/2017/02/Clinical-Outcome-Study-of-Knee.pdf
3. Walkay S, Munro W, Buchan M. Clinical Outcome Study of Knee Bracing in Osteoarthritis, A Retrospective and Prospective Study). BAPO Conference, Bolton UK 15 March 2008. Available at: http://www.anatomicalconceptsinc.com/wp-content/uploads/2017/02/V-VAS-Brace-prsentation-UK.pdf
4. Whiteside JW. V-Vas™ Orthosis: A New Concept in Unloader Knee Orthosis Design
, Anatomical Concepts Inc. 2013:1–5. Available at: http://www.anatomicalconceptsinc.com/wp-content/uploads/2017/01/Case-Study-V-Vas-Knee-Orthosis-Designs.pdf