Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

Completed · Phase 4

Conditions studied: Achilles Pain, Achilles Tendinosis, Heel Pain

In brief

This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other therapy. Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.

Key facts

Study ID

NCT00534781

Run by

ArthroCare Corporation

People needed

60

Starts

2007-09-01

Expected to finish

2010-09-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is at least 18 years of age
• Subject presents with pain associated with the Achilles tendon graded as >5 on a 0 to 10- point scale
• Subject's history and physical examination pinpoints anatomic origin of Achilles pain as associated with degeneration of the Achilles (non-insertional - proximal to retrocalcaneal bursa)
• Magnetic resonance imaging findings consistent with tendinosis
• 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…

• Use of NSAID's (e.g., ibuprofen, naproxen) within 2 weeks prior to treatment by this study
• Previous Achilles surgery on pathology to be treated by this study
• Heel pain associated with plantar fasciosis
• Multiple anatomic origins of 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
• Subject is currently participating in another drug/device study related to the degenerated Achilles
• Pregnant or pregnant suspected subjects prior to treatment
• History of Extracorporeal Shock Wave Treatment (ESWT) on foot to be treated by study
• Subject is incapable of understanding or responding to the study questionnaires

Where it is running

• Greater Chesapeake Orthopaedic Associates — Baltimore, Maryland, United States
• Orthopaedic Foot and Ankle Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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