High Quality Requirements
- AMBELIO commissioned quality tests to be carried out by France's national metrology and testing laboratory, LNE, which is accredited for CE marking assessment. The purpose of the testing was to analyse mechanical resistance and the efficacy of the constant cold while preventing skin burns, compared to competitor gel packs on the market.
All data are available in LNE report Folder P181269 - Document DE/2 - Page 1/14.
Mechanical resistance
Freezsnow cold packs have a mechanical resistance of more than 5N/cm².
TEMPERATURE
Freezsnow cold packs have a temperature of between 0°C and 5°C when placed on the skin after beeing frozen for more than 4 hours. This is not the case of competitor products. Competitor temperature obtained is -10°C, which may cause skin burns and patient discomfort.
EFFICACY
the efficacy of the constant cold delivered by AMBELIO's new patented device compared to competitor products is confirmed.
Bibliography
►Schröder D., Pâssier H.: Combination of cold and compression afterkneesurgery. KneeSurg, Sports Trauma, Arthroscopy93: 1-8, 1994.
►Sadoghi P, Hasenhütl S, Gruber G, Leitner L, Leithner A, Rumpold-Seitlinger G, Kastner N, Poolman RW, Glehr M. Impact of a new cryotherapy device on early rehabilitation after primary total knee arthroplasty (TKA): a prospective randomised controlled trial. Int Orthop. 2018 Jun; 42(6):1265-1273. doi: 10.1007/s00264-018-3766-5. Epub 2018 Jan 22.
►Scand J Med Sci Sports Cryotherapy; Fast-track arthroplasty; Pain relief; Prospective randomised trial; Total knee arthroplasty 2018 Mar;28(3):1252-1262. doi: 10.1111/sms.13014. Epub 2017 Dec 13.
►Jawad M, Sodhi N, Chughtai M, Newman JM, Khlopas A, Bhave A, Wagner T, Sultan AA, Roche M, Mont MA.CryotherapyTreatment After Arthroscopic Knee Debridement and ACL Reconstruction: A Review. Surg Technol Int. 2017 Jul 25;30:415-424.
►Guillot X, Tordi N, Prati C, Verhoeven F, Pazart L, Wendling D.Cryotherapy decreases synovial Doppler activity and pain in knee arthritis: A randomized-controlled trial. Joint Bone Spine. 2017 Jul;84(4):477-483. doi: 10.1016/j.jbspin.2016.09.004. Epub 2016 Nov 4.
►Kuyucu E, Bülbül M, Kara A, Koçyiğit F, Erdil M. Is cold therapy really efficient after knee arthroplasty? Ann Med Surg (Lond). 2015 Nov 11;4(4):475-8. doi: 10.1016/j.amsu.2015.10.019. eCollection 2015 Dec.
►Ni SH, Jiang WT, Guo L, Jin YH, Jiang TL, Zhao Y, Zhao J. Cryotherapy on postoperative rehabilitation of joint arthroplasty. Knee Surg Sports TraumatolArthrosc. 2015 Nov;23(11):3354-61. doi: 10.1007/s00167-014-3135-x. Epub 2014 Jun 14.