Clinical trial NCT06669741: Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear
Official title: Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Semiconductor Embedded Therapeutic Garments From Incrediwear
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Rotator Cuff Arthropathy of Left Shoulder (Disorder)
Rotator Cuff Arthropathy of Right Shoulder (Disorder)
Rotator Cuff Arthropathy of Bilateral Shoulders
Lead sponsor: Texas Bone and Joint
Sponsor class: OTHER
Collaborators: name: INCREDIWEAR HOLDINGS, INC.
First posted: 2024-11-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.
  * 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:

  * Participant will record pain medication type and quantity taken in a medications log. Only medications related to the treatment of shoulder pain or function will be required to be reported.
  * Participant will rate shoulder pain severity on a 1-10 VAS in a pain diary log.
  * Participant will record how long they have worn the shoulder brace and arm sleeve in device usage log.
* At the 12th week follow-up visit all study products, including the shoulder brace, arm sleeve, medications log, pain diary log, and device usage log.

  • Postoperative Recovery: 6 months and 1 year post surgery
* A follow-up phone call after 6 months and 1-year post-surgery will be administered.
* Participant will be asked to rate shoulder pain on a 1-10 Visual Analog Scale (VAS) and 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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing arthroscopic rotator cuff repair
2. Patients aged 18-75
3. Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
4. Patients who are willing and able to sign corresponding research subject consent form.

Exclusion Criteria:

1. Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
2. Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
3. Patient has had prior surgical treatment of a shoulder injury in the past 5 years
4. Patient has chronic pain conditions unrelated to shoulder condition
5. Patient has auto-immune or auto-inflammatory diseases
6. Patient has used tobacco within the last 90 days
7. Patient is not within the ages of 18-75
8. Patient has poorly controlled diabetes with HgA1c \> 7.5
9. Patient has an active infection (local or systemic)
10. Patient is unwilling or unable to sign the corresponding research subject consent form
11. 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.
12. Against medical advice (AMA)
13. Prisoner as indicated in the medical record

Primary outcomes:
measure: Arm Circumference Measure with a Measuring tape
timeFrame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Secondary outcomes:
measure: Visual Analogue Scale Measured by Scale
timeFrame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
measure: Range of Motion Measured by a Goniometer
timeFrame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Other outcomes:
Locations:
city: Denton
country: United States
facility: Medical City Denton
state: Texas
Study officials:
affiliation: Texas Bone and Joint
name: Christopher L. Flowers
role: PRINCIPAL_INVESTIGATOR
References: