Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis

Several million Americans receive treatment for heel pain each year, with more than two
million patients treated each year for plantar fasciitis and fasciosis alone.(2)
Conservative treatment options for recalcitrant heel pain include rest, stretching,
strengthening and massage, progressing to non-steroidal anti-inflammatory drugs (NSAIDs),
cox-2 inhibitors, steroid injections or iontophoresis with continued recalcitrance.(3;4)
Orthotics, heel cups, night splints and plantar strapping are other conservative options
frequently recommended by treating physicians.(4) Patient outcomes and response to
conservative measures is usually positive, with non-responsive cases, approximately 2% - 10%
of all presenting cases, receiving surgical care. Extracorporeal shockwave treatment (ESWT)
has recently been advocated for the recalcitrant cases and has shown to be effective in
60-80 percent of the cases.(5-7) In general, non-surgical treatment of plantar fasciosis and
tendinosis is believed to be unsuccessful, so that surgical treatment is required in about
25% of patients; however, results of traditional surgical treatments have been reported to
deteriorate with time.(8)

Clinical experience following RF-based plasma microtenotomy has demonstrated excellent
success in treating chronic, refractive tendinosis of the lateral epicondyle in the
elbow.(9) The investigators reported that this technique was technically simple to perform
and was much less invasive than conventional surgery. Patients had a rapid and uncomplicated
recovery and reported minimal to no pain 7-10 days following the procedure; their pain
relief persisted or improved through 24 months. Magnetic resonance imaging correlated well
with clinical results. The RF-based plasma microtenotomy procedure is also being used
successfully in tendons in the shoulder, knee, foot and ankle and in the plantar fascia. A
randomized controlled study was conducted with the aim of determining whether bRF-based
microtenotomy was effective for treating chronic supraspinatus tendinosis (10). Longitudinal
postoperative recovery through one year for patients treated using RF-based plasma
microtenotomy was compared to patients undergoing subacromial decompression. Both patient
groups demonstrated significant improvement after each respective procedure and longitudinal
recovery profiles were statistically similar. Early experience using this procedure for foot
and ankle tendons, including the Achilles tendon, posterior tibial tendon, peroneal tendon,
and plantar fascia revealed over 90% good to excellent results, reflecting the results shown
by patients treated for tendinosis in the elbow (11)

Further investigation of optimal placement of this surgical approach into the standard of
care treatment paradigm for treating plantar fasciosis and Achilles tendinosis would be
beneficial. It is not known whether this RF-based plasma microsurgery might be more
optimally placed earlier on within the standard of care treatment algorithm.

The purpose of this study is to determine the magnitude of improvement for pain and
functional symptoms over a two year period after enrollment into the registry study in
patients presenting with chronic heel pain and undergoing standard of care treatment.
Standard of care will include traditional conservative care measures, ESWT,
radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.

Inclusion Criteria:

- Subject is at least 18 years of age

- Subject's history and physical examination pinpoints anatomic origin of heel pain as
associated with plantar fasciosis (tenderness with palpation and local pressure over
the medial calcaneal tuberosity on passive dorsiflexion) or Achilles tendinosis
(tenderness upon palpation and local pressure at the insertion site)

- Subject (or guardian) must sign IRB approved informed consent form

- Subject is willing and able to complete required follow-up

Exclusion Criteria:

- Previous fascia surgery on pathology to be treated by this study

- Multiple anatomic origins of heel pain in foot to be treated by study

- History or documentation showing Type I and Type II Diabetes Mellitus

- Physical findings and documentation of coagulopathy, infection, tumor or other
systemic disease(s)

- History or documentation showing peripheral vascular disease or autoimmune disease

- History or documentation of fibromyalgia

- Subject is currently participating in another drug/device study related to the
injured plantar fascia or Achilles tendon

- Pregnant or pregnant suspected subjects prior to treatment

- Subject is incapable of understanding or responding to the study questionnaires