Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridement

NCT ID: NCT00534781

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-09-30

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.

Conditions

Achilles Pain; Achilles Tendinosis; Heel Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

plasma microtenotomy

Group Type: EXPERIMENTAL

plasma microdebrider

Intervention Type: DEVICE

Coblation of the Achilles

B

Standard Surgical Debridement

Group Type: ACTIVE_COMPARATOR

Mechanical Surgical Debridement

Intervention Type: PROCEDURE

Surgical Debridement of the Achilles

Interventions

plasma microdebrider

Coblation of the Achilles

Intervention Type: DEVICE

Mechanical Surgical Debridement

Surgical Debridement of the Achilles

Intervention Type: PROCEDURE

Other Intervention Names

TOPAZ MicroDebrider

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ArthroCare Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry Philbin, D.O.

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Foot and Ankle Center, Columbus, OH

Locations

Greater Chesapeake Orthopaedic Associates

Baltimore, Maryland, United States

Orthopaedic Foot and Ankle Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

SM-107WW

Identifier Type: -

Identifier Source: org_study_id