Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
To determine the magnitude of improvement for pain and function symptoms over a two year
 period after enrollment into the registry study in patients presenting with chronic heel pain
 and receiving standard of care treatment. Standard of care will include traditional
 conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel
 debridement and/or surgical release.
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