Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

NCT06625723 | Not Yet Recruiting

• 1 other identifier: ColumbiaOrthopedics
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries; Shoulder Impingement

Outcome Measures

Primary Outcomes (2)

• Narcotic Use

  Total amount of daily narcotics consumed for pain control.

  Daily

• Patient Reported Sleep Quality

  Using questionnaire to evaluate patient satisfaction with sleep and associated symptoms. Scale will be subjective 1-10

  3 months

Secondary Outcomes (2)

• Sleep Data

  3 months

• Sleep Data

  3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard postoperative care for patients undergoing rotator cuff repair.

Procedure: Standard postoperative care

Sleep Aid Group

EXPERIMENTAL

Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.

Procedure: Standard postoperative care; Device: Surgical Recovery Systems Sleep Aid

Interventions

Standard postoperative care PROCEDURE

This will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.

Control Group; Sleep Aid Group

Surgical Recovery Systems Sleep Aid DEVICE

Sleep assistive device

Sleep Aid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rotator Cuff Tear

You may not qualify if:

• Prior ipsilateral shoulder surgery
• Ipsilateral upper extremity neurological deficit

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cole Morrissette, MD

CONTACT

3322153690; crm2224@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Orthopedic Surgeon

Model Details: Two treatment arms, one standard postoperative protocol following rotator cuff repair surgery. The second arm with the same protocol, with the addition of the sleep assistive device.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 3, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share