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Harmony® Vacuum System Reimbursement Reference Guide
Harmony® Vacuum System Reimbursement Reference Guide
1
The Harmony® Vacuum System
Features and Benefits
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Clinical Research Summary
Results: Four surveys were excluded from
The Benefits of Vacuum the final analysis; (survey not complete,
subject did not use both suspension systems,
Compared to Other vacuum system was not electronic, and
Suspension Methods incorrect amputation level). The ABC scores
for the remaining 9 surveys were Vacuum
Elevated vacuum suspension systems Suspension (80±10) and Pin Suspension
manage limb volume fluctuation, a problem (65±20), resulting in a confidence level of
that people with limb loss are challenged 95% (p=0.0359) in favor of vacuum.
with. Over time and on a daily basis, these Subjects (n=13) were also surveyed on a
volume changes can affect how the socket variety of related problems experienced with
fits. When the limb volume increases, the suspension systems. Results for pistoning,
socket becomes tighter, exerting pressure, blisters, volume change, difficulty knee
restricting blood flow, and allowing for bending, redness, falls, and walking time, all
accumulated cell waste. When limb volume favored vacuum suspension over pin
decreases, the socket is loose-fitting often suspension; however the results were not
causing pressure to bony prominences, significant, possibly due to small sample
which may result in pain and/or injury to the size.1
limb.1
An earlier study by Beil5 (2004) compared pin
Vacuum Compared to Pin suspension to suction suspension (n=9) by
Suspension measuring impulse and peak pressures in the
socket during ambulation. Results: During
Ferraro (2011) conducted an outcomes study
stance phase there was no difference between
(n=13) comparing pin suspension to
the two suspension methods (p=0.076);
electronic vacuum suspension. All subjects
however, during swing phase, differences
used each suspension system for at least 30
were significant (positive pressure impulses
days. 2 A validated measurement tool called
p=0.008, average positive pressure p-0.004,
the Activity-specific Balance Confidence
distal negative impulse p=0.053 and peak
(ABC) scale was used to evaluate the subject’s
pressure p=0.026) demonstrating that pin
confidence when performing certain
suspension exerts an occlusive pressure on
activities (n=16) with regard to balance.
the proximal tissues of the residual limb,
Subjects taking the survey rated their
while at the same time generating
confidence in performing each activity on a
considerable suction at the distal end of the
scale from 0 (no confidence) to 100
socket, and that these pressures are likely
(completely confident). 3 A score below 67
causing both the persistent and the day-to-
indicates a risk for falling.4
day skin issues witnessed with pin
suspension users.
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The Benefits of Vacuum Compared to
Other Suspension Methods (cont.)
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Clinical Research Summary
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The Harmony®: Early Fitting of
Transtibial Amputees with Unhealed Results: Despite having such a large open wound,
when tested using the Harmony®, the subject’s LCI
Residual Limb Wounds (cont.) score was 41 and BI was 85. Additionally, after 3-4
hours of continuous ambulation and standing
pain and possibly less healing. However, wound- activities, VAS (pain) score was 0. At the end of 4
healing and pain perception scores were not months, the wound area was reduced to 28cm2,
statistically significant between the groups. which equated to a 34% reduction in wound area.
Conclusion: The authors concluded that that early
use of the Harmony® in the presence of open 1
Amputee Coalition. Limb loss statistics.
ulcers/wounds did not impede healing, nor did it http://limblossawareness.org/about-llam/limb-loss-
increase pain. statistics/index.php.
2
Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, et al.
When Compared to Amputees without Estimating the prevalence of limb loss in the United States:
2005 to 2050. Arch Phys Med Rehabil. 2008;89(3):422‐429.
Ulcer/Wound Healing Failure 3
HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost
An earlier study by Brunelli,12 conducted at the same and Utilization Project (HCUP). Rockville, MD: AHRQ; 2009.
4
Traballesi M, Averna T, Delussu AS, Brunelli S. Trans-tibial
rehabilitation facility, reported on 24 transtibial prosthesization in large area of residual limb wound: Is it
amputees; 7 subjects with ulcer/wound healing possible? A case report. Disability and Rehabilitation: Assistive
failure fit with the Harmony® and 17 subjects with no Technology. 2009;4(5):373–375.
5
ulcer/wound healing failure fitted with a standard Van Velzen AD, Nederhand MJ, Emmelot CH, Ijzerman MJ.
Early treatment of trans-tibial amputees: Retrospective analysis
PTB socket (PTB Group). Locomotor Capability of early fitting and elastic bandaging. Prosthet Orthot Int
Index (LCI): Subjects were measured using LCI to 2005;29:3 –12.
6
determine prosthetic use. At nine months, the Gauthier-Gagnon C, Grise MC, Potvin D. Predisposing
factors related to prosthetic use by people with a transtibial
Harmony® group scored 36±6.7 on the LCI compared
and transfemoral amputation. JPO. 1998;10(4):99-109; Waters
to the PTB group which scored 28±4.2. Pain RL, Mulroy S. The energy expenditure of amputee gait. Gait
Perception: Subjects were measured using the and Posture. 1999:9(3):207-231; Bowker JH, Michael JW
Visual Analog Scale (VAS) for pain perception. VAS (ed):In: Atlas of limb prosthetics: Surgical, prosthetic and
rehabilitation principles. St. Louis: Mosby Year Book,
scores were favorable for the Harmony® group both 1992;381-387.
at 1 month (6.3±2.2 compared to 7.5±2.5) and at 9 7
Trabalessi M, Delussu AS, Fusco A, et al. Residual limb
months (4.6±1.3 compared to7±1.8). Conclusion: wounds or ulcers heal in transtibial amputees using an active
suction socket system. A randomized controlled study. Eur J
The authors concluded that patients fit with the Phys Rehabil Med 2012:48:1-2
Harmony® were compliant in its use, and their 8
Dudek NL, Marks MV, Marshll SC, Chardon JP.
ulcers/wounds improved during the study. Dermatologic conditions associated with use of lower extremity
prosthesis. Arch Phys Med Rehabil. 2005:86:659-663
Large Wound Case Study 9
Meulenbelt HE, Geertzen JH, Jonkman MF, Dijkstra PU.
Determinants of skin problems of the stump in lower-limb
Traballesi4 also reported on a 60 year-old, amputees. Arch Phys Med Rehabil. 2009:90:74-81
dysvacular, transtibial amputee with a 43.5cm2 10
Munin et al. Predictive factors for successful early prosthetic
category IV wound on his residual limb. ambulation among lower-limb amputees. J Rehabil Res Dev.
2001:38;4
Measurements included the LCI for prosthetic use, 11
White SA, Thompson MM, Zickerman AM, et al. Lower limb
the Barthel Index (BI) for functional independence, amputation and grade of surgeon. Br J Surg 1997; 84(4): 509-
and digital photos of the wound for healing. The 11.
12
subject wore the Harmony® 8 hours per day for 4 Brunelli S, Averna T, Delusso AS, Traballesi M. Vacuum
assisted socket system in trans-tibial amputees: Clinical report.
months and participated in outpatient gait therapy. Orthopädie-Technik Quarterly, English edition. 2009; II:2-4
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Vacuum Studies Bibliography
Reverse Chronological Order
2. Kahle JT, Orriola JJ, Johnston W, Highsmith MJ. The effects of vacuum-assisted
suspension on residual limb physiology, wound healing, and function: A systematic
review. Technol Innov. 2014; 1(15): 333-341.
http://www.ingentaconnect.com/content/cog/ti/2014/00000015/00000004/art00009
3. Kahle JT, Highsmith MJ. Transfemoral interfaces with vacuum assisted suspension
comparison of skeletal kinematics, pressure and preference: Ischial containment versus
brimless. J Rehabil, Res, Dev. 2013; 50(9): 1241-1252.
http://www.rehab.research.va.gov/jour/2013/509/jrrd-2012-01-0003.html
5. Hoskins RD, Sutton EE, Kinor D, Schaeffer JM, Fatone S. Using vacuum-assisted
suspension to manage residual limb wounds in persons with Transtibial amputation: A
case series. POI. 2013;05 DOI:10.1177/0309364613487547
http://www.researchgate.net/publication/236920322_Using_vacuum-
assisted_suspension_to_manage_residual_limb_wounds_in_persons_with_transtibial_a
mputation_A_case_series
6. Traballesi M, Delussu AS, Fusco A, et al. Residual limb wounds or ulcers heal in
transtibial amputees using an active suction socket system. A randomized controlled
study. Eur J Phys Rehab Med 2012;48:1-2.
http://www.ncbi.nlm.nih.gov/pubmed/22641248
8. Gerschutz MJ, Denune JA, Colvin JM, and Schober G. Elevated vacuum suspension
influence on lower limb amputee’s residual limb volume at different vacuum pressure
settings. JPO 2010;22(4):252-256.
http://courses.washington.edu/rehab427/Fall%202010/Student%20Papers%20for%20
Review/Phil%20-%20Gerschutz%20(2010).pdf
9. Gerschutz MJ, Haynes ML, Colvin JM, Nixon D, Denune JA, and Schober G. A vacuum
suspension measurement tool for use in prosthetic research and clinical outcomes:
Validation and analysis of vacuum pressure in a prosthetic socket. JPO 2010;22(3): 172-
176.
http://journals.lww.com/jpojournal/Fulltext/2010/07000/A_Vacuum_Suspension_Meas
urement_Tool_for_Use_in.8.aspx?WT.mc_id=HPxADx20100319xMP
10. Traballesi M, Averna T, Delussu AS, et al. Trans-tibial prosthesization in large area of
residual limb wound: is it possible? A case report. Disabil Rehabil Assist Technol
2009;4:373–375.
http://www.hsantalucia.it/ric/attivita2009/AutoPlay/Docs/I%20pagine%20pubblicazio
ni/295-Trans-tibial%20prosthesization.pdf
11. Brunelli S, Averna T, Delusso S, et al. Vacuum assisted socket system in trans-tibial
amputees: Clinical report. The Orthopadie Technik, 2009;2:2-8. http://www.ot-
forum.de/verlag_ot/otquarterly/e30554/infoboxContent30555/OT_Quarterly_2_09_72_
dpi_ger.pdf
12. Fairley M. ‘Hanging Tight’: elevated vacuum suspension systems step forward. The O&P
Edge, March 2008. http://www.oandp.com/articles/2008-03_03.asp
13. Street G. Vacuum suspension and its effects on the limb. The Orthopadie Technik,
2006;4:1–4 http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/Street-
0661_OT_GB.pdf
14. Beil TL, Street GM. Comparison of interface pressures with pin and suction suspension
systems. J Rehabil Res Dev 2004;41:821–828.
http://www.rehab.research.va.gov/jour/04/41/6/pdf/Beil.pdf
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Vacuum Studies Bibliography
Reverse Chronological Order
15. Goswami J, Lynn R, Street G, Harlander M: Walking in a vacuum-assisted socket shifts the
stump fluid balance Prosthet Orthot Int 2003;27(2):107-113
http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/harmony_article_1.pdf
16. Beil TL, Street GM, Covey SJ. Interface pressures during ambulation using suction and
vacuum-assisted prosthetic sockets. J Rehabil Res Dev 2002;39(6):693-700.
http://www.rehab.research.va.gov/jour/02/39/6/pdf/Beil.pdf
17. Board WJ, Street GM, Caspers C A comparison of trans-tibial amputee suction and vacuum
socket conditions. Prosthet Orthot Int 2001;25:202-209
http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/harmony_article_3.pdf
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