Achilles Pain Clinical Trial
Official title:
Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03274557 -
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose
|
N/A |