Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- FAAM Sports Subscale
研究概览
简要总结
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
详细描述
The objective of this clinical trial is to evaluate both the safety and efficacy of using the NuShield® allograft in addition to standard of care surgical procedures in subjects requiring surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:
-
Questionnaires
-
Visual Analog Scale Foot and Ankle (VAS FA)
-
FAAM Sport
-
PROMIS Global Health SF
-
Tegner Activity Scale
-
Foot and Ankle Outcomes Instrument (Q1, Q2)
-
Swelling assessments
-
Ultrasound imaging for tendon thickness, gliding and adhesion formation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 60 inclusive
- •If female, actively practicing a medically relevant method of contraception, abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
- •Have a diagnosis of one of the following in relation to the peroneal tendon:
- •Tendonitis with MRI confirmation
- •Synovial inflammation
- •Diagnosis resulting from acute injury to the tendon
排除标准
- •BMI equal to or greater than 35
- •Prior injury to the peroneal tendon
- •Collagen disorders
- •Inflammatory arteriopathies
- •Immune compromised
- •Less than 6 months between injury and proposed surgery date
- •Steroid injection within the past 6 weeks localized to the treatment area
- •Pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to treatment
- •History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or have received such medications during the screening period, or are anticipated to require such medications during the course of the study
- •Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
- •History of radiation therapy of the affected foot
- •Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- •Currently involved in medical litigation, including Worker's Compensation claims of any type
- •Unable to understand the objectives of the trial
- •Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
- •Having a known history of poor adherence with medical treatment
- •Express an unwillingness to receive human allograft tissue
结局指标
主要结局
FAAM Sports Subscale
时间窗: 6 Months
Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes
VAS Foot and Ankle Pain
时间窗: 6 Months
Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome
次要结局
- Adverse Events(up to 1 year)
- Swelling assessment by investigator(6 and 12 months)
- PROMIS Global Health Subscale(6 and 12 months)
- Tegner Activity Scale(6 and 12 months)
- Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)(6 and 12 months)