Radiofrequency-based Plasma Microdebridement Compared to Surgical Microdebridement for Treating Achilles Tendinosis: A Prospective, Randomized, Controlled Multi-Center Study"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 12 months
次要结局
- To determine whether recovery from postoperative pain, quality of life and clinical events are equivalent for treatment groups.(12 Months)