Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

July 10, 2013 updated by: ArthroCare Corporation

Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Greater Chesapeake Orthopaedic Associates
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Orthopaedic Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
plasma microtenotomy
Device: plasma microdebrider
Coblation of the Achilles
Other Names:
  • TOPAZ MicroDebrider
ACTIVE_COMPARATOR: B
Standard Surgical Debridement
Procedure: Mechanical Surgical Debridement
Surgical Debridement of the Achilles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ArthroCare Corporation

Investigators

  • Principal Investigator: Terry Philbin, D.O., Orthopedic Foot and Ankle Center, Columbus, OH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (ESTIMATE)

September 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM-107WW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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