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Sponsored by: |
ArthroCare Corporation |
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Information provided by: | ArthroCare Corporation |
ClinicalTrials.gov Identifier: | NCT00534781 |
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 | Intervention | Phase |
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Achilles Pain Achilles Tendinosis Heel Pain |
Device: plasma microdebrider Procedure: Mechanical Surgical Debridement |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Radiofrequency-Based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study" |
Estimated Enrollment: | 60 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Arms | Assigned Interventions |
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A: Experimental
plasma microtenotomy
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Device: plasma microdebrider
Coblation of the Achilles
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B: Active Comparator
Standard Surgical Debridement
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Procedure: Mechanical Surgical Debridement
Surgical Debridement of the Achilles
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Terry Philbin, D.O. | Orthopedic Foot and Ankle Center, Columbus, OH |
Responsible Party: | ArthroCare Corporation ( Wendy Winters, Sr. Clinical Research Associate ) |
Study ID Numbers: | SM-107WW |
Study First Received: | September 24, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00534781 History of Changes |
Health Authority: | United States: Institutional Review Board |
Achilles Tendinosis Tendinitis Achilles Tendinosis Achilles Tendinitis Coblation |
Bipolar Radiofrequency Surgical Debridement Debridement Heel Pain Achilles Pain |
Tendinopathy Tendon Injuries Muscular Diseases Musculoskeletal Diseases |
Wounds and Injuries Disorders of Environmental Origin Pain |
Tendinopathy Tendon Injuries Muscular Diseases |
Musculoskeletal Diseases Wounds and Injuries Disorders of Environmental Origin |