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Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

Primary Purpose

Achilles Pain, Achilles Tendinosis, Heel Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
plasma microdebrider
Mechanical Surgical Debridement
Sponsored by
ArthroCare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Pain focused on measuring Achilles, Tendinosis, Tendinitis, Achilles Tendinosis, Achilles Tendinitis, Coblation, Bipolar Radiofrequency, Surgical Debridement, Debridement, Heel Pain, Achilles Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Greater Chesapeake Orthopaedic Associates
  • Orthopaedic Foot and Ankle Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

plasma microtenotomy

Standard Surgical Debridement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.

Full Information

First Posted
September 24, 2007
Last Updated
July 10, 2013
Sponsor
ArthroCare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00534781
Brief Title
Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement
Official Title
Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ArthroCare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Pain, Achilles Tendinosis, Heel Pain
Keywords
Achilles, Tendinosis, Tendinitis, Achilles Tendinosis, Achilles Tendinitis, Coblation, Bipolar Radiofrequency, Surgical Debridement, Debridement, Heel Pain, Achilles Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
plasma microtenotomy
Arm Title
B
Arm Type
Active Comparator
Arm Description
Standard Surgical Debridement
Intervention Type
Device
Intervention Name(s)
plasma microdebrider
Other Intervention Name(s)
TOPAZ MicroDebrider
Intervention Description
Coblation of the Achilles
Intervention Type
Procedure
Intervention Name(s)
Mechanical Surgical Debridement
Intervention Description
Surgical Debridement of the Achilles
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Philbin, D.O.
Organizational Affiliation
Orthopedic Foot and Ankle Center, Columbus, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Chesapeake Orthopaedic Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Orthopaedic Foot and Ankle Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States

12. IPD Sharing Statement

Links:
URL
http://topazinfo.com
Description
Related Info

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Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

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