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.|
|ClinicalTrials.gov Identifier: NCT00534781|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 11, 2013
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups. [ Time Frame: 12 Months ]
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 ClinicalTrials.gov 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|
|Principal Investigator:||Terry Philbin, D.O.||Orthopedic Foot and Ankle Center, Columbus, OH|