Incrediwear for Rotator Cuff Injury Recovery

Overseen By Christopher L. Flowers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Bone and Joint

Disqualifiers: Neurological conditions, Heart conditions, Auto-immune, others

Compensation: Varies

Number of Visits: 7

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

How does the Incrediwear treatment for rotator cuff injury recovery differ from other treatments?

The Incrediwear treatment is unique because it likely involves wearable technology that may aid in monitoring and enhancing recovery, unlike traditional methods that focus on immobilization or physical therapy alone. This approach could offer a novel way to support tendon healing and rehabilitation. ^{1 2 3 4 5}

Research Team

Christopher L. Flowers

Principal Investigator

Texas Bone and Joint

Eligibility Criteria

This trial is for individuals who have had arthroscopic surgery to repair a rotator cuff tear and are experiencing postoperative pain, limited range of motion, or swelling. Specific eligibility criteria were not provided.

Inclusion Criteria

I am having surgery to repair my rotator cuff.

I am willing and able to follow the study's schedule and rules.

I am willing and able to sign the consent form for this study.

Exclusion Criteria

My diabetes is not well-managed with an HgA1c over 7.5.

I have a neurological condition like multiple sclerosis or Parkinson's disease.

I had shoulder surgery within the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery

Participants undergo arthroscopic rotator cuff repair surgery and receive study materials

1 day

1 visit (in-person)

Postoperative Recovery

Participants wear shoulder brace and arm sleeve, with follow-up visits at 2, 6, and 12 weeks post-surgery

12 weeks

3 visits (in-person)

Extended Follow-up

Participants receive follow-up phone calls at 6 months and 1 year post-surgery to assess pain and function

1 year

2 calls (virtual)

Treatment Details

Interventions

• Incrediwear

Trial Overview The study is testing the effectiveness of Incrediwear shoulder sleeves compared to a placebo in improving recovery outcomes after rotator cuff repair surgery. Participants will be randomly assigned to use either the actual product or a placebo.

Participant Groups

Group I: Incrediwear Product Active Control 1 Intervention

To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo.

Group II: Placebo Placebo Group 1 Intervention

To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo.

Who Is Running the Clinical Trial?

Texas Bone and Joint

Lead Sponsor

Trials

2

Recruited

230+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+

Medical City Denton

Collaborator

Trials

2

Recruited

230+

References

1. United States pubmed.ncbi.nlm.nih.gov

Postoperative Mobilization After Superior Rotator Cuff Repair: Sling Versus No Sling: A Randomized Prospective Study. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Physical therapy and precision rehabilitation in shoulder rotator cuff disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Rotator Cuff Retears. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Abduction Brace Wearing Compliance on the Results of Arthroscopic Rotator Cuff Repair. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. [2022]