A Randomized Prospective Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Effusion/swelling Measurements
研究概览
简要总结
The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Participant population includes female or male patients in relative good health, 18 to 65 years old. The investigators will compare participants with Incrediwear and placebo Incrediwear products during the first 6-month postoperative period. The main question it aims to answer are:
- Will the Incrediwear products help participants to decrease postoperative pain and swelling?
- Will the Incrediwear products help the participants by increasing the range of motion in a shorter amount of time than the placebo group? Participants will be asked to maintain a journal documenting surgical site pain, pain medication type and quantity taken.
Researcher will compare 90 participants enrolled in one of six groups, double blinded and randomly assigned, to see if the Incrediwear products assist in controlling postoperative swelling, and increase range of motion in a shorter amount of time.
- ACL participants randomly assigned the Incrediwear product, placebo product, or none
- ACL+MCL participants randomly assigned the Incrediwear product, placebo product, or none
详细描述
Researcher will identify patients of the Primary Investigator (PI) who are candidate for the study. Subjects must otherwise be in good health as determined by medical history, physical examination, vital signs, and applicable laboratory tests and receive medical clearance for the procedure by the PI.
Subjects must be able to read and sign an informed consent form indicating understand the purpose of, and the procedures required for the study, and are willing to participate and comply with the study protocol.
This will be a prospective study to evaluate the benefit of the Incrediwear product after ACL repair or ACL+MCL repair via arthroscopic surgery. Subjects who fit the inclusion and exclusion criteria will be reviewed on a subject-by-subject basis at the time of informed consent documentation.
Preoperative and Post-Operative Measurements:
Subjective: Participants rates surgical site pain, on a 0-10 Visual Analogue Scale (VAS) pain scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded stratified randomization of subjects from two arms into one of three groups per arm.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consented to protocol
- •Compliant to protocol
- •BMI less than 35
- •Undergoing ACL or ACL+MCL within 30 days
排除标准
- •Rheumatoid Arthritis
- •Poorly controlled diabetes (HgA1c > 7.5)
- •Previous blood clots
- •BMI greater than 35
- •Varicosities on operative leg
- •Pain management patient
- •Prior knee surgery to the operative / study knee
- •Worker's Comp patients
- •Pregnancy
结局指标
主要结局
Effusion/swelling Measurements
时间窗: 180 days
The Patella sweep test is used to measure effusion. The measured rating is a quantity on a scale of 0 to 3, with 0 rating no fluid-wave while perorming a downward stroke, 1 a large bulge, 2 medial fluid returns to position without performing a downward sweep, and 3 excell of fluid that makes it impossible to stroke the medial fluid away. Measurements will be taken at set times during the postoperative period.
Subjective Patient Pain Experience
时间窗: 180 days
The Visual Analogue Scale (VAS), a 0 to 10 scale, with 0 being no pain and 10 being the worst pain will be used to measures pain intensity.
Pain Medication Usage
时间窗: 180 days
Patient will document pain medication type and quantity taken in a daily pain diary.
Range of Motion
时间窗: 180 days
The patient's range of motion captured at all time points during the postoperative period.
次要结局
未报告次要终点