Clinical trial NCT00534781: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Achilles Pain
Achilles Tendinosis
Heel Pain
Keywords: Achilles
Tendinosis
Tendinitis
Achilles Tendinosis
Achilles Tendinitis
Coblation
Bipolar Radiofrequency
Surgical Debridement
Debridement
Heel Pain
Achilles Pain
Lead sponsor: ArthroCare Corporation
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Greater Chesapeake Orthopaedic Associates
state: Maryland
city: Columbus
country: United States
facility: Orthopaedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center, Columbus, OH
name: Terry Philbin, D.O.
role: PRINCIPAL_INVESTIGATOR
References: