A Multi-center, Open Label, Economic Outcome Study Comparing the Recovery of Patients Receiving CLARIX® CORD 1K as an add-on Treatment During Surgical Tendon Repair to Control Patients Receiving Standard of Care Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
研究概览
简要总结
Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons due to tendon adhesion complications. Functional recovery is compromised by limiting post-operative range of motion, mobility, and can lead to considerable amount of post-operative pain for the patient.
Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and anti-scarring agent and promoting wound healing towards regeneration.
Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the overall functional recovery of the patient.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18 years to 80 years of age
- •Confirmed tendon pathology via MRI, if clinically necessary, with planned surgical repair that have failed conservative management (PT) for a minimum of 2 months for chronic and partial thickness tears; acute full thickness tears or tendon rupture immediately eligible.
- •Willing to follow the instructions and complete the visits required.
排除标准
- •Psychologically unstable
- •Acute infections that, in the opinion of the investigator, may complicate healing
- •Currently receiving chemotherapy
- •Systemic inflammatory arthritis or Rheumatoid arthritis
- •Uncontrolled diabetes as measured by A1C>12
- •Bleeding disorders
- •Unable to provide informed consent
- •Has received oral or parenteral corticosteroids or cytotoxic agents for seven consecutive days in the period of 30 days before surgery OR has received a local steroid injection within 7 days of surgery
- •Immunocompromised patients
- •Active malignancy other than non-melanoma skin cancer
- •Untreated alcohol or substance abuse issues at the time of screening
- •Pregnant women at the time of randomization
- •Currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
- •Allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM).
- •Will undergo significant concurrent procedures with the tendon procedures on the affected foot that, in the opinion of the Investigator, may complicate healing or alter the post-operative visit schedule
研究组 & 干预措施
CLARIX® CORD 1K
Applied in addition to standard of care tendon repair surgery.
干预措施: CLARIX® CORD 1K graft (Other)
Standard of care tendon repair surgery only
结局指标
主要结局
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
时间窗: Baseline and 1 Year
次要结局
未报告次要终点