Rotator Cuff: Does the Vascularity Matter and the Role for PINPOINT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- PINPOINT System-ASES
研究概览
简要总结
The overall goal of doing this study is to improve long term patient function and outcomes in the healing rates of Rotator Cuffs. The investigators would also like to see if this method can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.
详细描述
Background or rationale for this study:
4.5 million Patient's seek medical care for shoulder pain annually in the United States.
250,000 patients receive rotator cuff surgery in the United States annually. Those rotator cuff surgeries produce a societal savings of $3.44 billion per year; averaging $13,771.00 per patient younger than age 61. In which case rotator cuff tears Increases with age.
The Societal and Economic Value of Rotator Cuff Repair (AAOS) 2015 Rotator cuff repairs result in a lifetime societal savings in the U.S. of approximately $3.44 billion annually. Societal savings offset the direct costs of treatment in patients younger than age 61, resulting in an average net savings of $13,771 per patient. This number significantly increased to $77,662.00 for patients younger than 40 years of age.
Common problem, a 55 year-old man injured his left arm. He uses a sling and has difficulties performing simple activities. 1 week later he falls develops immediate pain in his shoulder. On examination he is unable to move his left arm in any upward or sideways direction without supporting it with his other arm. Radiographs he brought show no signs of shoulder osteoarthritis, dislocation, or fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of requiring Rotator Cuff repair surgical treatment
- •Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
- •Willing and able to sign a study specific informed consent form to participate.
- •Age range of ≥ 30 years old and ≤ 80 years old at time of surgery.
- •Male or female.
排除标准
- •Previous Rotator cuff repair or shoulder surgery.
- •Active systemic infection or infection at the operative site.
- •Co-morbid medical conditions of the upper extremities that may affect the neurological and/or pain assessment.
- •History of an osteoporotic fracture.
- •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
- •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
- •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
- •Insulin-dependent type 1 or type 2 diabetes.
- •Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
- •Pregnant, or intend to become pregnant, during the course of the study.
- •Severe obesity (Body Mass Index > 40).
研究组 & 干预措施
PINPOINT system
The operative intervention will proceed as current standard protocol dictates for the described procedure. No changes in the operative technique will be undertaken apart from injection of the dye and visualization with the camera. The idea would be to place the Pinpoint probe within the subacromial space, to check the vascular status of the tendon, and then take a bite of the tendon and place the pinpoint back to check if the vascularity has decreased. The Indocyanine Green dye kit will be used along with the PINPOINT system .
干预措施: PINPOINT System (Device)
结局指标
主要结局
PINPOINT System-ASES
时间窗: Change from baseline at 24 months
American Shoulder and Elbow Surgeons questionnaire this will be used for scoring
次要结局
- PINPOINT System-DASH(Change from baseline at 24 months)
- PINPOINT System-SF-36(Change from baseline at 24 months)
- PINPOINT System-UCLA(Change from baseline at 24 months)
- PINPOINT System-SF-12(Change from baseline at 24 months)
研究者
Nirav Amin, MD
M.D. Associate Professor
Loma Linda University