All the procedures done at The Center for Morton’s Neuroma are FDA approved. Our Ultrasound Guided Ablations are a combination of ultrasound guidance and percutaneous ablation procedures, both of which have been approved and used for over 20 years. The use of ultrasound guided ablation techniques to treat Morton’s neuroma has been shown to be effective through many clinical trials. For history of ultrasound guided ablations in the treatment of Morton’s neuroma see below.
The FDA is a Federal Department for Drug (and device) approval. All the devices and disposables we use are FDA approved. Any kits we use are FDA approved. We only use FDA cleared devices and kits for our Platelet Rich Plasma procedures and our for procedures to treat Fat Pad Atrophy. Please enquire if you would like copies of the FDA approvals for these devices. Our Platelet Rich Plasma and our procedures for Fat Pad Atrophy are allowed and approved under Section 361 and/or The Same Day Surgical Exception (21 CFR 1271.15(b).
In the 1950’s, Ellington became one of the first to recognize the importance of liquid nitrogen for cryosurgical applications. In the 1960’s, the invention of other devices, including a liter liquid nitrogen spray in a handheld form help popularize the use of cryoablation for skin lesions. These devices improve the depth of penetration of the cryolesion and thus improved the efficacy for the treatment of many skin conditions. In 1963 Cooper(1) a New York neurosurgeon, reported on a liquid nitrogen probe capable of achieving a temperature of -196°C. The Cooper device was an automated system that utilized the continuous flow of liquid nitrogen through a closed self-contained cryoprobe. This unit was one of the first to use pressurized liquid nitrogen pumped through a cryoprobe and was capable of temperature controlled regulation of the freezing process. This device made possible the ability to rapidly create a continuous large volume freeze in deep seated tissues.
In 1987 Ravikumar(2) and his associates reported their surgical experience with hepatic cryosurgery for metastatic colon cancer to the liver. Their development of liquid nitrogen cooled probes suitable for surgical placement established the field of cryosurgery. The development of these liquid nitrogen, cryo-probes dramatically augmented the volume of tissue that could be frozen by low temperatures and increased the types of tissues that could be ablated. The key development that sparked the widespread use of cryoablation was the fusing of cryoablation with real time imaging guidance in the form of intraoperative ultrasound. Real time ultrasound was used to verify the extensive treatment and to measure the size of the iceball that was created by freezing. Freezing for three cycles was established as an effective means of cryoablation. Further experimentation by Onik et al in 1995 (3) confirmed the efficacy of ultrasonography for monitoring cryoablation. Cryoablation for the use of Morton’s neuroma was first described by Hodor et al in 1997(4). Subsequently, a number of research articles have validated that approach.
The basic technique for Radiofrequency Ablation was described over century go by D’Arsonval(5) who in 1918 first demonstrated that when RF waves passed through tissue, they caused an increase in tissue temperature. In the early 1900s radio frequency ablation was used was already being used in a few medical applications such as the treatment of bladder neoplasms using cauterization through a cystoscope. Radiofrequency ablations became widely popularized after the introduction of the Bovie knife in 1928 by Cushing and Bowie(6). The first generation Bovie knife was a monopolar electrode similar to that used for contemporary percutaneous radio frequency ablation techniques. In 1990, two independent investigators used a modification of prior radio frequency techniques to create coagulation necrosis that could be applied via the percutaneous route. McGahan et al(7) described their research in the English literature and in the same year Rossi et al(8) described a similar technique in Italian literature. These investigators replaced the Bovie knife with us with specially designed RF needles insulated to the distal tip.
In 1992 McGahan et al(9) showed that ultrasound could be used to both monitor the radio frequency needle placement and to assess the exogenic response in the tissue surrounding the RF needle during ablation. In 1993 this technique was used for RFA of liver tumors in humans(10). It was soon investigated by others and shortly thereafter became commercially available. Modern RF generators with variable wattages can manipulate the power deposition resulting in pinpoint accuracy in tissue necrosis. Local tissue characteristics and tissue interaction with the radiofrequency current are important parameters taken into account with modern percutaneous radio frequency ablations.
The use of radio frequency ablation for the treatment of Morton’s neuroma was first described by Genon et al in 2010(11) and then by Moore et al in 2012(12) and Cohen et al in 2013(13). Ultrasound guided radio frequency ablation was first described by Chuter in 2012(14) . Subsequently, a number of research articles have validated that approach.
Percutaneous tissue ablation using ethanol (neurolytic ablation) is not new. One of the first descriptions of its use was in the treatment of renal cyst by Bean in 1981.(15) The technique used by Bean more than 40 years ago, has not changed significantly to the present. However, Bean used contrast fluoroscopy as guidance while we use ultrasound guidance for Morton’s neuroma. In 1986, Livraghi (16) et al described the use of ultrasound guided needle placement into 14 hepatic lesions. All patients were treated with percutaneous injection of 95% ethanol into two tumors that were less than 4 cm in diameter. This work established the feasibility and value of percutaneous alcohol injections. Highly concentrated ultrasound guided percutaneous alcohol ablation for the treatment of Morton’s neuroma was first described by Pasquale et al in 2015(17) and then by Perini et al in 2016.(18) Subsequently, numerous papers have validated that approach.
Our Medical Director is Board Certified in Anesthesia and Pain Medicine and was trained in the best medical institutions in the United States (Mass General Hospital and Brigham and Women’s Hospital). Our Podiatrist is a Board-Certified Podiatric Surgeon, board certified in Podiatric Medicine, forefoot, rearfoot reconstructive and ankle surgery.
