Effect of Biophysical Stimulation on Intraspongious Bone Edema in Anterior Cruciate Ligament Reconstruction

Summary

The following study has as main objective to evaluate whether the use of I-ONE® therapy can reduce post-operative pain thanks to the modulation of inflammation in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury if applied 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment). Both groups will be able to take anti-inflammatory drugs for pain control as per normal clinical practice. The secondary objective of the study are: quantify the reduction in the size of the bone bruise area, improving the level of knee function and the amount of anti-inflammatory drugs used in the aforementioned patients in the postoperative period compared to a control group.

Timeline

Start

2017-11-20

Primary completion

2023-05-26

Completion

2023-05-26

Publications

• Results Papalia R, Torre G, Vasta S, Zampogna B, Pedersen DR, Denaro V, Amendola A. Bone bruises in anterior cruciate ligament injured knee and long-term outcomes. A review of the evidence. Open Access J Sports Med. 2015 Feb 18;6:37-48. doi: 10.2147/OAJSM.S75345. eCollection 2015.
• Results Massari L, Benazzo F, De Mattei M, Setti S, Fini M; CRES Study Group. Effects of electrical physical stimuli on articular cartilage. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:152-61. doi: 10.2106/JBJS.G.00581. No abstract available.
• Results Zorzi C, Dall'Oca C, Cadossi R, Setti S. Effects of pulsed electromagnetic fields on patients' recovery after arthroscopic surgery: prospective, randomized and double-blind study. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):830-4. doi: 10.1007/s00167-007-0298-8. Epub 2007 Feb 28.
• Results Moretti B, Notarnicola A, Moretti L, Setti S, De Terlizzi F, Pesce V, Patella V. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study. BMC Musculoskelet Disord. 2012 Jun 6;13:88. doi: 10.1186/1471-2474-13-88.
• Results Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7. Epub 2013 Dec 20.

Drugs

Indications

No indication recorded.