Clinical Outcomes

Clinical Outcomes

WillowWood is committed to providing clinicians with outcome measures in order to help improve the quality of care for amputees. Our research is possible through collaborative efforts with clinicians, universities and companies and is supported through grants from regional and national organizations.

Elevated Vacuum

Summary Statement

Vacuum suspension was first introduced to the prosthetic field in 19951 and became commercially available in 19992. Since then, numerous published research documents have demonstrated the clinical value of this prosthetic suspension system. The results report quantified improvements associated with wearing an elevated vacuum suspended socket such as reduced pistoning or vertical movement of the socket related to the residual limb2-5, reduced residual limb volume fluctuations2,6,7, reduction of positive pressures on the residual limb tissues from the prosthetic socket3,8, improvements in gait and balance2,3,9-11, and documentation of wound healing while continuing to wear a prosthesis11-14.  Qualitative results indicate higher satisfaction and quality of life of amputee prosthesis users utilizing EVS3,6,9-11,13.  To investigate the documented reports of wound healing with elevated vacuum suspension, WillowWood partnered with The Ohio State University and developed a method to quantify skin health and blood circulation15.  The study found a promotion of skin barrier function, increase blood perfusion during walking, and a reduction in reactive hyperemia following socket doffing when using elevated vacuum suspension compared to non-vacuum suspension16.  Taken together, the results suggest that EVS-dependent differences in the prosthetic socket residual limb interface account for residual limb health improvement in part by beneficial changes in residual limb perfusion and stress applied to the soft tissues of the residual limb.

Research by WillowWood

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Peer Reviewed: 
Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation, Advances in Wound Care, Volume 6, Number 7
Elevated Vacuum Suspension Preserves Residual-limb Skin Health in People with Lower-limb Amputation: Randomized Clinical Trial, Journal of Rehabilitation Research and Development, Volume 53, Number 6

Other References:
Quantification of Residual Limb Skin Health and Circulation in Response to Elevated Vacuum Suspension, AAOP 41st Annual meeting and Scientific Symposium, February 19, 2015

Click here for full bibliography

 

  1. Caspers CA. Hypobarically-controlled artificial limb for amputees. US patent number 5,549,709.
  2. Board W, Street G, Caspers C. A comparison of transtibial amputee suction and vacuum socket conditions. Prosthetics and Orthotics International. 25, 202-209. (2001).
  3. Kahle J, Highsmith J. Transfemoral sockets with vacuum-assisted suspension comparison of hip kinematics, socket position, contact pressure, and preference: Ischial containment versus brimless. Journal of Rehabilitation Research and Development. 50, 1241-1252. (2013).
  4. Wernke M, Schroeder R, Haynes M, Nolt L, Albury A, Colvin J. Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health. Adv Wound Care. 2017. 6 (7): p 233-239.
  5. Gerschutz M, Haynes M, Colvin J, Denune J. Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension.  Journal of Prosthetics and Orthotics. 27 (4) 161-165. (2015)
  6. Goswami J, Lynn R, Street G, Harlander M. Walking in a vacuum-assisted socket shifts the stump fluid balance. Prosthetics and Orthotics International. 23. 107-113. (2003).
  7. Sanders J, Harrison D, Myers T, Allyn K. Effects of elevated vacuum on in-socket residual limb fluid volume: Case study results using bioimpedance analysis. Journal of Rehabilitation Research and Development. 48. 1231-1248. (2011).
  8. Beil T, Street G, Covey S. Interface pressures during ambulation using suction and vacuum-assisted prosthetic sockets. Journal of rehabilitation Research and Development. 39. 693-700. (2002).
Summary Statement

The team at WillowWood was the first to quantify the effects of elevated vacuum suspension on skin tissue health.  The study found a promotion of skin barrier function, increase blood perfusion during walking, and a reduction in reactive hyperemia following socket doffing when using elevated vacuum suspension compared to non-vacuum suspension1.  Taken together, the results suggest that EVS-dependent differences in the prosthetic socket residual limb interface account for residual limb health improvement in part by beneficial changes in residual limb perfusion and stress applied to the soft tissues of the residual limb.  This hypothesis is supported by the literature that shows reduced pistoning or vertical movement of the socket related to the residual limb2-5, reduced residual limb volume fluctuations2,6,7, reduction of positive pressures on the residual limb tissues from the prosthetic socket3,8, improvements in gait and balance2,3,9-11 that could lead to the reports of wound healing11-14.

Previously, the team showed that the quality of socket fit matters, where both tight and loose sockets will result in greater movement of the limb inside the socket compared to a well-fit socket on a bench top model15.  Taken this into account and building upon a previous clinical trial16, the team conducted a study to measure limb motion inside of a 3 different sockets using an inductive sensor; a well fit, a slightly loose, and a slightly tight.  The study was presented at national trade shows.  It confirmed the findings of the bench top study, where a well-fit socket resulted in the least amount of motion.  Interesting, a tight fitting socket resulting in the most motion for the prosthesis users.  The use of elevated vacuum suspension significantly reduced movement, particularly non-vertical movement of the limb.  This could explain the reports of better proprioception with elevated vacuum suspended prostheses.  Further extrapolating the results of the study to project the limb movement that would occur if a prosthesis user walked the daily recommended 10,000 steps, they would experience over 55 meters of motion inside their socket with a passive suction socket.  With elevated vacuum suspension, this movement could be reduced to as little as 5 meters over the same amount of steps.  This would certainly reduce stress on the limb and prevent wounds from developing.

Research by WillowWood

Download Summary PDF

Peer Reviewed: 
Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension, Journal of Prosthetics and Orthotics, Volume 27, Number 4, 2015
Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health, Advances in Wound Care, Volume 00, Number 00

 

Click here for full bibliography

  1. Rink C, Wernke M, Powell H, Gynawali S, Schroeder R, Kim J, Denune J, Gordillo G, Colvin J, Sen C. Elevated Vacuum Suspension Preserves Residual Limb Skin Health in Lower Limb Amputees: Randomized Clinical Trial.  2016; 53 (6): 1121-1132.
  2. Board W, Street G, Caspers C. A comparison of transtibial amputee suction and vacuum socket conditions. Prosthetics and Orthotics International. 25, 202-209. (2001).
  3. Kahle J, Highsmith J. Transfemoral sockets with vacuum-assisted suspension comparison of hip kinematics, socket position, contact pressure, and preference: Ischial containment versus brimless. Journal of Rehabilitation Research and Development. 50, 1241-1252. (2013).
  4. Wernke M, Schroeder R, Haynes M, Nolt L, Albury A, Colvin J. Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health. Adv Wound Care. 2017. 6 (7): p 233-239.
  5. Gerschutz M, Haynes M, Colvin J, Denune J. Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension.  Journal of Prosthetics and Orthotics. 27 (4) 161-165. (2015)
  6. Goswami J, Lynn R, Street G, Harlander M. Walking in a vacuum-assisted socket shifts the stump fluid balance. Prosthetics and Orthotics International. 23. 107-113. (2003).
  7. Sanders J, Harrison D, Myers T, Allyn K. Effects of elevated vacuum on in-socket residual limb fluid volume: Case study results using bioimpedance analysis. Journal of Rehabilitation Research and Development. 48. 1231-1248. (2011).
  8. Beil T, Street G, Covey S. Interface pressures during ambulation using suction and vacuum-assisted prosthetic sockets. Journal of rehabilitation Research and Development. 39. 693-700. (2002).
  9. Kahle J, Highsmith J. Transfemoral interfaces with vacuum assisted suspension comparison of gait, balance, and subjective analysis: Ischial containment versus brimless. Gait and Posture. 40, 315-320. (2014).
  10. Samitier C, Guirao L, Costea M, Camos J, Pleguezuelos E. The benefits of using a vacuum-assisted socket system to improve balance and gait in elderly transtibial amputees. Prosthetics and Orthotics International. (2014).
  11. Ferraro C. Outcomes Study of Transtibial Amputees Using Elevated Vacuum Suspension in Comparison with Pin Suspension. Journal of Prosthetics and Orthotics. 23 (2) p 78-81. (2011)
  12. Traballesi M, Delussu A. Fusco A, Iosa M, Averna T, Pellegrini R, Brunelli S. Residual limb wounds or ulcers heal in transtibial amputees using an active suction socket system. A randomized controlled study. Eur. J. Phys. Rehabil. Med. 48. 613-623. (2012).
  13. Hoskins R. Sutton E. Kinor D. Schaeffer J, Fatone S. Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: A case series. Prosthetics and Orthotics International. (2012)
  14. Brunelli S, Averna T, Delusso S, Trabellesi M. Vacuum assisted socket system in transtibial amputees: Clinical report. Orthopaedic Technik Quarterly. (2009).
  15. Wernke M, Schroeder R, Haynes M, Nolt L, Albury A, Colvin J. Progress toward optimizing prosthetic socket fit and suspension using elevated vacuum suspension to promote residual limb health.  Advances in Wound Care. 2017. DOI: 10.1089/wound.2016.0719.
  16. Gerschutz M, Haynes M, Colvin J, Denue J. Dynamic Effectiveness Evaluation of Elevated Vacuum Suspension.  2015; 27 (4): p 161 – 165.

Liner Technology

Summary Statement

Common prosthetic liner materials insulate the residual limb1,2, resulting in elevated socket temperatures and increased perspiration.  Heat and perspiration are common complaints leading to a decreased quality of life reported by amputees3.  Confining the residual limb in a warm and moist environment may be responsible for infections4 and the formation of blisters.5-7 Furthermore, Legro8 noted that excessive perspiration can negatively affect suspension of the prosthesis.  WillowWood designed a solution that incorporates phase change material into a gel liner to proactively manage sweat.  A series of outcome tests have been completed which show a significant reduction in sweat and skin temperature when using the SmartTemp liner compared traditional gel liners.  These results have been presented at industry trade shows and published in peer-reviewed journals9.

Research by WillowWood

Download Summary PDF

Peer Reviewed: 
SmartTemp Prosthetic Liner Significantly Reduces Residual Limb Temperature and Perspiration, Journal of Prosthetics and Orthotics, Volume 27, Number 4, 2015

Other References:
Regulation of Temperature and Perspiration within a Prosthetic Socket to Improve Amputee Quality of Life, ISPO World Congress 2015, Lyon, France, June 24, 2015

 

Click here for full bibliography

  1. Klute G, Rowe G, Mamishev A, Ledoux W. The thermal conductivity of prosthetic sockets and liners. Prosthet Orthot Int 2007;31:292–299.
  2. Webber C, Klittich M, Dhinojwala A, Davis B. Thermal conductivities of commercially available prosthetic materials. J Prosthet Orthot 2014;26:212–215.
  3. Hagberg K, Branemark R. Consequences of non-vascular transfemoral amputation: a survey of quality of life, prosthetic use and problems. Prosthet Orthot Int 2001;25:186–194.
  4. Kohler P, Lindh L, Bjorklind A. Bacteria on stumps of amputees and the effect of antiseptics. Prosthet Orthot Int 1989;13:149–151.
  5. Naylor P. Experimental friction blisters. Br J Dermatol 1955;67: 327–342.
  6. Naylor P. The skin surface and friction. Br J Dermato 1955;67:239–246.
  7. Akers WA, Sulzberger MB. The friction blister. Mil Med 1972;137:1–7.
  8. Legro M, Reiber G, Del Aguila M, et al. Issues of importance reported by persons with lower limb amputations and prostheses. J Rehabil Res Dev 1999;36:155–163.
  9. Wernke M, Schroeder R, Kelley C, Denune J, Colvin J. SmartTemp Prosthetic Liner Significantly Reduces Residual Limb temperature and Perspiration. Journal of Prosthetics and Orthotics. 2015; 27 (4): p. 134-139.
WillowWood is committed to providing outcome measures. Have a question about the research we’re doing?
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Edwin & Kathryn Arbogast Award Winners

The Edwin and Kathryn Arbogast Prosthetic Student Award honors scientific papers submitted for presentation at the American Orthotic and Prosthetic Association’s (AOPA) national meeting dealing with scientific studies that are deemed to have potential for clinical impact. The purpose of the award is to encourage students and prosthetic residents to display outstanding posters at the AOPA National Meeting.

2016

Tyler Klenow: A Metric to Quantify the “Dead Spot” Phenomenon in Prosthetic Gait: An Analysis of Sagittal Center of Pressure Progression and Its Velocity

2015

Lisa Abernethy: Going Back In Time: A Content Analysis On The Media Portrayal Of Characters With Antiquated Prostheses

2014

Lauren Levey: Lateralization of Motor Control in the Lower Extremity

2011

Chrysta Irolla: Unilateral Transtibial Amputee Dynamic Stability Margin During Human Walking

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