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

NCT00420875 | Withdrawn Phase 4

• 1 other identifier: SM-706WW
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Plantar Fasciosis, Achilles Tendinosis

Keywords

plantar fasciitis; plantar fasciosis; Achilles tendinosis; Achilles tendinitis; heel pain; fasciosis; fasciitis; tendinosis; tendinitis; conservative treatment

Outcome Measures

Primary Outcomes (1)

• Ankle Hind Foot Scale (AHS)

  6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months

Secondary Outcomes (1)

• Visual Analog Scale (VAS), SF-36 Quality of Life, Patient Satisfaction

  6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months

Interventions

TOPAZ MicroDebrider DEVICE

The TOPAZ MicroDebrider will be used for patients that fail conservative care. Under sterile conditions in the operating room, patients will be given intravenous sedation (drugs that make you sleepy and unaware of your surroundings) in a hand vein and local anesthetic (drugs to numb the area where the surgical procedure will be done). Depending on the technique used the study doctor may or may not make an incision (cut) about 1 inch long on the side of your foot to expose your tendon. If the study doctor chooses to use the percutaneous method, an incision will not be made. The study doctor will put the tip of the TOPAZ MicroDebrider device (which is about 1/16th of an inch long) into the tendon. A current of energy will be applied on and around the tendon. Steri strips will be placed on the skin to close the area treated.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ArthroCare Corporation: lead

Study Sites (3)

Foot Care Physicians

Mesa, Arizona, 85204, United States

Location

Foot and Ankle Institute of Santa Monica

Santa Monica, California, 90403, United States

Location

Foot and Ankle Clinic of Oakwood

Oakwood, Georgia, 30566, United States

Location

Related Publications (31)

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Related Links

• Click here for information about TOPAZ (the device to be used in the study)

MeSH Terms

Conditions

Fasciitis, Plantar; Fasciitis; Tendinopathy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Foot Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Babak Baravarian, DPM

  Foot and Ankle Institute of Santa Monica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: June 1, 2007
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (3)