Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

NCT ID: NCT06625723

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Standard postoperative care for patients undergoing rotator cuff repair.

Group Type ACTIVE_COMPARATOR

Standard postoperative care

Intervention Type PROCEDURE

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

Sleep Aid Group

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

Group Type EXPERIMENTAL

Standard postoperative care

Intervention Type PROCEDURE

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

Surgical Recovery Systems Sleep Aid

Intervention Type DEVICE

Sleep assistive device

Interventions

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Standard postoperative care

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

Intervention Type PROCEDURE

Surgical Recovery Systems Sleep Aid

Sleep assistive device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Rotator Cuff Tear

Exclusion Criteria

* Prior ipsilateral shoulder surgery
* Ipsilateral upper extremity neurological deficit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cole Morrissette

Resident Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Cole Morrissette, MD

Role: CONTACT

3322153690

Other Identifiers

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ColumbiaOrthopedics

Identifier Type: -

Identifier Source: org_study_id

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