Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Semiconductor Embedded Therapeutic Garments From Incrediwear
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Arm Circumference Measure with a Measuring tape
研究概览
简要总结
To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling.
详细描述
Study Screening/pre-operative appointment
- The surgeon confirms the participant meets the inclusion criteria and is scheduled for surgery in the next few weeks.
- The surgeon will discuss the study and possible risks/benefits of being in the research.
- The study team will measure the participant wrist, arm, and shoulder circumference.
- The participant will rate their shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; shoulder function with the American Shoulder and Elbow Surgeons Score (ASES) scale, and function limitations using the Western Ontario Rotator Cuff Index (WORC) questionnaire.
- The study team will measure the patient's shoulder's range of motion, stability, and strength.
- Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
• Day of Surgery
- A study packet will be given to the participant by the study staff. The packet will include a study number assignment, the products assigned, and the patient study journal. The participant, surgeon, and clinical staff will not know which group the participant is in.
- After surgery, the surgeon and PI, Dr. Flowers, will place the shoulder brace and arm sleeve according to the random assignment in the study packet. An abduction sling will then be placed on top of the shoulder brace and arm sleeve by Dr. Flowers.
- Participant will be instructed to wear the shoulder brace and arm sleeve for at least 20 hours per day, including overnight, for 12 weeks post-surgery.
- Participant will be instructed on the length of time to wear the shoulder abduction sling by the surgeon.
- The clinical staff will take arm circumference measurements post-surgery.
• Postoperative Recovery: Weeks 1-12
-
Follow-up visits will be at 2 weeks, 6 weeks, and 12 weeks post-surgery. During follow-up visits:
-
The clinical staff will take arm swelling measurements.
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Participant shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.
-
The clinical staff will measure shoulder's range of motion, stability, and strength.
-
Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
-
Daily reported measures include:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing arthroscopic rotator cuff repair
- •Patients aged 18-75
- •Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- •Patients who are willing and able to sign corresponding research subject consent form.
排除标准
- •Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- •Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- •Patient has had prior surgical treatment of a shoulder injury in the past 5 years
- •Patient has chronic pain conditions unrelated to shoulder condition
- •Patient has auto-immune or auto-inflammatory diseases
- •Patient has used tobacco within the last 90 days
- •Patient is not within the ages of 18-75
- •Patient has poorly controlled diabetes with HgA1c > 7.5
- •Patient has an active infection (local or systemic)
- •Patient is unwilling or unable to sign the corresponding research subject consent form
- •Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
- •Against medical advice (AMA)
- •Prisoner as indicated in the medical record
结局指标
主要结局
Arm Circumference Measure with a Measuring tape
时间窗: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
To measure swelling in the upper arm, a soft tape measure to measure the circumference of the arm at multiple points at the writs, mid-forearm, axilla, and oblique. A 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is not optimal. Less than 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is optimal.
次要结局
- Visual Analogue Scale Measured by Scale(Preop appointment, Postop Day 42, Day 84, Day 168, Day 364)
- Range of Motion Measured by a Goniometer(Preop appointment, Postop Day 42, Day 84, Day 168, Day 364)
研究者
Christopher Flowers, MD
Orthopaedic Surgeon
Texas Bone and Joint