Band Connect for Shoulder Surgery Recovery

Overseen By Kira Smith, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Hemiarthroplasty, Revision TSA, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

499 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.

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 coordinators or your doctor.

What data supports the effectiveness of the treatment Band Connect for shoulder surgery recovery?

The research on Enhanced Recovery After Surgery (ERAS) for spinal surgery shows that a structured, evidence-based approach can improve surgical outcomes and patient satisfaction, which might suggest similar benefits for shoulder surgery recovery with Band Connect. Additionally, the use of patient-reported outcome measures (PROMs) in shoulder surgery has shown that patients can effectively track their recovery, potentially enhancing the effectiveness of treatments like Band Connect. ^{1 2 3 4 5}

Is Band Connect generally safe for human use?

The available research does not provide specific safety data for Band Connect or similar treatments under different names. The studies focus on safety in surgical procedures and monitoring systems, but do not directly address Band Connect. ^{6 7 8 9 10}

How does the Band Connect treatment differ from other treatments for shoulder surgery recovery?

The Band Connect treatment is unique because it likely incorporates smart technology, similar to smartbands used in other surgeries, to enhance communication between patients and surgical teams and support self-management, potentially leading to faster recovery and reduced hospital stays. ^{11 12 13 14 15}

Research Team

Robert Gillespie, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for individuals undergoing total shoulder replacement or rotator cuff repair who will participate in physical therapy. It aims to include those willing to use the Band Connect health platform during their home exercise programs.

Inclusion Criteria

Chart Review Inclusion Criteria:

I had a primary shoulder replacement surgery.

My surgery was done by Dr. Robert Gillespie and I had physical therapy at University Hospitals.

Exclusion Criteria

I stayed in the hospital for more than 3 days after my shoulder surgery.

I am having a second surgery on my rotator cuff.

Shoulder injuries related to workers compensation or involved in any pending litigation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physical therapy rehabilitation using the Band Connect platform or standard care

6 months

Regular in-person and virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Band Connect

Trial Overview The study tests Band Connect, a digital tool designed to improve patient adherence to prescribed home exercises post-surgery. The goal is to see if it boosts engagement and satisfaction, and whether it can increase revenue per patient.

Participant Groups

Group I: Group 1 Band Connect Experimental Treatment 1 Intervention

Patients in group 1 will be set up with the Band Connect platform and build their treatment plan at the first in-clinic visit.

Group II: Group 2 Standard Care Active Control 1 Intervention

Group 2 will consist of retrospective chart review to as act a control group. Charts will be pulled from 1/1/2019-12/31/2023.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Band Connect

Collaborator

Trials

1

Recruited

500+

Findings from Research

A new web-based system called PROMs 2.0 was developed to facilitate the administration of patient-reported outcome measures, allowing patients to track their progress, specifically focusing on those undergoing arthroscopic subacromial decompression using the Oxford shoulder score (OSS).

In a pilot study, 83% of eligible patients who showed improvement in their OSS chose to skip routine follow-up appointments, indicating that the system may enhance patient satisfaction and reduce clinic visits while still monitoring recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures: an on-line system empowering patient choice. Wilson, J., Arshad, F., Nnamoko, N., et al.[2021]

The implementation of the Enhanced Recovery After Surgery (ERAS) program in spinal fusion procedures significantly reduced the average hospital length of stay (LOS) for patients, with reductions from 6.06 to 3.33 days for anterior lumbar interbody fusion (ALIF), 3.08 to 1.3 days for anterior cervical discectomy and fusion (ACDF), and 6.7 to 4.8 days for posterior fusion cases, all with p-values < 0.001.

Despite the reduced LOS, the ERAS program did not lead to an increase in overall complications, and patient satisfaction with care management was high, with 86.5% of surveyed patients expressing satisfaction with the care received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Enhanced Recovery After Surgery for fusion in degenerative spine surgery: impact on outcome, length of stay, and patient satisfaction. Debono, B., Corniola, MV., Pietton, R., et al.[2020]

Anatomic total shoulder arthroplasty patients using a neutral rotation sling position experienced less night pain and improved range of motion, supported by moderate evidence from the review of 14 studies.

The review highlighted that many factors influencing treatment outcomes, such as telemedicine and immediate range of motion exercises, had only preliminary or conflicting evidence, indicating a need for more standardized and high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with better treatment outcome of physical therapy interventions after shoulder arthroplasty: A systematic review. Claes, A., Mertens, MG., Verborgt, O., et al.[2022]

A survey of 350 NHS shoulder surgeons in the UK revealed that 79% use outcome measures in their practice, with the Oxford shoulder score being the most popular among them, utilized by 69% of respondents.

The study highlights the importance of adopting validated outcome measures across all surgical specialties to improve treatment assessments and enhance transparency in surgical performance evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of shoulder scoring systems and outcome measures in the UK. Varghese, M., Lamb, J., Rambani, R., et al.[2021]

Patients undergoing shoulder arthroplasty at an orthopedic specialty hospital (OSH) had a significantly shorter average length of stay (1.31 days) compared to those at a tertiary referral center (TRC) (1.85 days), despite similar patient characteristics across both groups.

Readmission rates were comparable between the OSH (1.5%) and TRC (0.7%), suggesting that the shorter hospital stay at the OSH did not compromise patient safety or outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Length of stay after shoulder arthroplasty-the effect of an orthopedic specialty hospital. Padegimas, EM., Zmistowski, BM., Clyde, CT., et al.[2018]

The application of Enhanced Recovery After Surgery (ERAS) protocols in laparoscopic bariatric surgery significantly reduces both operative time and length of hospital stay, based on a meta-analysis of 7 studies involving 3264 patients.

There were no significant differences in the rates of major or minor postoperative complications, readmissions, or reoperations between patients receiving ERAS management and those receiving traditional care, indicating that ERAS is a safe approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Meta-analysis on safety of application of enhanced recovery after surgery to laparoscopic bariatric surgery]. Wang, W., Yang, C., Wang, B.[2019]

The ClassIntra system demonstrated an almost perfect inter-rater agreement (Cohen Kappa coefficient of 0.87) for grading intraoperative adverse events (iAEs) in elective abdominal surgeries, indicating it is a reliable tool for assessing surgical complications.

Higher severity grades in ClassIntra were linked to an increased risk of postoperative complications, with intraoperative hypotension and organ injuries being the strongest predictors, highlighting the importance of monitoring these events during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-Rater Agreement of the Classification of Intraoperative Adverse Events (ClassIntra) in Abdominal Surgery. Krielen, P., Gawria, L., Stommel, MWJ., et al.[2023]

Adverse events in surgical departments are mostly registered, with 92.5% of departments reporting such events, although 42.7% still rely on paper methods instead of digital systems.

The National Surgical Adverse Event Registration (LHCR) software is currently operational in only 24.6% of departments, primarily due to challenges in creating an import file from hospital information systems, indicating a significant opportunity for improvement and wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Automated registration of adverse events in surgical patients in the Netherlands: the current status]. Marang-van de Mheen, PJ., Kievit, J.[2015]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

In a study involving 281 morbidly obese patients undergoing bariatric surgery, the use of an Internet application for at-home follow-up successfully detected all early complications, demonstrating its safety and effectiveness.

Out of 264 patients who completed the 10-day follow-up, only 1.1% required surgical revision for complications, indicating that the connected surveillance protocol was effective in monitoring patient recovery and ensuring high satisfaction rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connected Surveillance for Detection of Complications After Early Discharge from Bariatric Surgery. Neuberg, M., Blanchet, MC., Gignoux, B., et al.[2021]

The study presents a straightforward technique for restraining the shoulder after injury or surgery, which may enhance patient comfort and recovery.

This method aims to provide effective immobilization, potentially improving healing outcomes for patients with shoulder injuries or post-operative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple shoulder restraint. Williamson, JB.[2019]

The use of smartbands in a perioperative ERAS program for minimally invasive colorectal surgery did not significantly improve compliance with early mobilization or reduce postoperative complications compared to standard protocols.

However, smartbands enhanced communication and self-management, leading to a quicker return to preoperative functional status and a reduction in hospital stay by approximately 1 day for patients without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartband Use During Enhanced Recovery After Surgery Facilitates Inpatient Recuperation Following Minimally Invasive Colorectal Surgery. Yin, TC., Huang, CW., Tsai, HL., et al.[2021]

In a study of 60 patients who underwent arthroscopic rotator cuff repair, those receiving Enhanced Recovery After Surgery (ERAS) nursing combined with limb training showed significantly improved shoulder joint range of motion and neurological function compared to those receiving routine nursing.

The experimental group reported lower pain and swelling, higher self-efficacy, and a lower complication rate, indicating that ERAS nursing combined with rehabilitation training is more effective for recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of evidence-based nursing combined with enhanced recovery after surgery on shoulder joint function and neurological function after arthroscopic rotator cuff injury repair. He, L., Li, Y., Liao, X., et al.[2023]

This study aims to enhance postoperative recovery by using activity trackers to provide continuous feedback on step counts for patients undergoing major abdominal surgeries, with a total of 120 participants randomized into groups with and without feedback.

The primary goal is to increase the average step count during the first 5 postoperative days, addressing the challenge of objectively measuring and implementing early mobilization in clinical practice, which is crucial for successful recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Wolk, S., Meißner, T., Linke, S., et al.[2018]

A study of 71 patients who underwent rotator cuff surgery found that both day-hospitalization and in-patient rehabilitation provided similar outcomes in terms of pain, range of motion, and complications, indicating that either option can be effective for recovery.

However, patients who had more complex surgeries experienced higher levels of pain and stiffness by the fifteenth day post-surgery, suggesting that the complexity of the surgery may influence early recovery experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation after shoulder rotator cuff surgery: in-patient or day-hospitalization (about 76 cases)]. Delbrouck, C., Dauty, M., Huguet, D., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures: an on-line system empowering patient choice. [2021]

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

Benefits of Enhanced Recovery After Surgery for fusion in degenerative spine surgery: impact on outcome, length of stay, and patient satisfaction. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Factors associated with better treatment outcome of physical therapy interventions after shoulder arthroplasty: A systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The use of shoulder scoring systems and outcome measures in the UK. [2021]

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

Length of stay after shoulder arthroplasty-the effect of an orthopedic specialty hospital. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Meta-analysis on safety of application of enhanced recovery after surgery to laparoscopic bariatric surgery]. [2019]

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

Inter-Rater Agreement of the Classification of Intraoperative Adverse Events (ClassIntra) in Abdominal Surgery. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Automated registration of adverse events in surgical patients in the Netherlands: the current status]. [2015]

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

Patient safety in plastic surgery: identifying areas for quality improvement efforts. [2022]

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

Connected Surveillance for Detection of Complications After Early Discharge from Bariatric Surgery. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A simple shoulder restraint. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Smartband Use During Enhanced Recovery After Surgery Facilitates Inpatient Recuperation Following Minimally Invasive Colorectal Surgery. [2021]

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

Effects of evidence-based nursing combined with enhanced recovery after surgery on shoulder joint function and neurological function after arthroscopic rotator cuff injury repair. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. [2018]

15. Netherlands pubmed.ncbi.nlm.nih.gov

[Rehabilitation after shoulder rotator cuff surgery: in-patient or day-hospitalization (about 76 cases)]. [2021]