Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534781
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
ArthroCare Corporation

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Achilles Pain Achilles Tendinosis Heel Pain Device: plasma microdebrider Procedure: Mechanical Surgical Debridement Phase 4

Detailed Description:

Typically, Achilles pain results from overuse of the calf muscles (e.g., running, jumping) or abnormal biomechanical stress on the foot and ankle.(1). Overuse can injure the fibrous tissue that connects the heel to the calf muscles. Treating an injured Achilles tendon is crucial to avoid exacerbating the injury further, which may lead to partial or full rupture of the tendon.

Tendinosis, sometimes complicated by partial rupture, appears to be the major lesion in chronic Achilles tendinopathy; the paratenon is rarely involved. Important features are a lack of inflammatory cells and a poor intrinsic ability to heal.

Several million Americans receive treatment for tendinosis each year, with more than 200,000 patients treated each year for Achilles tendonitis and tendinosis alone.(5) Conservative treatment options for Achilles pain include rest, stretching, strengthening, ice and/or physical therapy. In general, non-surgical treatment of Achilles tendonitis 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. (3).

The purpose of this study is to evaluate longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores in patients with symptomatic Achilles tendinosis treated using radiofrequency-based plasma microtenotomy compared to standard surgical debridement.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
Study Start Date : September 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: A
plasma microtenotomy
Device: plasma microdebrider
Coblation of the Achilles
Other Name: TOPAZ MicroDebrider

Active Comparator: B
Standard Surgical Debridement
Procedure: Mechanical Surgical Debridement
Surgical Debridement of the Achilles

Primary Outcome Measures :
  1. To determine whether patients treated using plasma microtenotomy demonstrate equivalent longitudinal improvement of AOFAS Ankle-Hindfoot Scale scores through 12 months postoperatively to patients treated using standard surgical debridement. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups. [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534781

United States, Maryland
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, United States, 21218
United States, Ohio
Orthopaedic Foot and Ankle Center
Columbus, Ohio, United States, 43231
Sponsors and Collaborators
ArthroCare Corporation
Principal Investigator: Terry Philbin, D.O. Orthopedic Foot and Ankle Center, Columbus, OH

Additional Information:
Responsible Party: ArthroCare Corporation Identifier: NCT00534781     History of Changes
Other Study ID Numbers: SM-107WW
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by ArthroCare Corporation:
Achilles Tendinosis
Achilles Tendinitis
Bipolar Radiofrequency
Surgical Debridement
Heel Pain
Achilles Pain

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries