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Closed Suction Drainage in Shoulder Arthroplasty

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound drainage
Total Shoulder Arthroplasty
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty

Exclusion Criteria:

  • Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection

Sites / Locations

  • Columbia University medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TSA with drain placement

TSA without drain placement

Arm Description

Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.

Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.

Outcomes

Primary Outcome Measures

Change in Hemoglobin level
To assess blood loss
Change in Hematocrit level
To assess blood loss

Secondary Outcome Measures

Total length of hospital stay
Calculated in number of days
Total cost incurred during hospital stay
Calculation will include the cost of the surgical procedure
Change in Elbow Surgeons Evaluation Form (ASES) score
To determine the longterm effect of drain usage on functional shoulder score-total score from 0-100 where 0= worse pain and functional loss /disability
Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection
Total Drain Output record
Calculated total blood loss in ml
Number of subjects that presented with anatomic healing after total shoulder arthroplasty
To be determined by shoulder ultrasound results
Change in Disabilities of the Arm Shoulder and Hand (DASH) Score
To determine the longterm effect of drain usage on functional shoulder score- measured from 0-100 a higher score indicates greater disability

Full Information

First Posted
May 4, 2016
Last Updated
March 25, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02767453
Brief Title
Closed Suction Drainage in Shoulder Arthroplasty
Official Title
The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 24, 2019 (Actual)
Study Completion Date
January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the limited effectiveness of drains during Total Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease infection rates, swelling,and the number of dressing changes required during a hospital stay. The use of drains has been heavily investigated in the hip and knee replacement literature, but there have been no investigations regarding their use in shoulder replacements, despite frequent use. Clinical benefit has not been consistently documented regarding drain usage in hip and knee arthroplasty and the investigators hypothesize that they are of limited utility in total shoulder arthroplasty as well. The investigators will perform a prospective investigation of total shoulder arthroplasty patients- dividing them into two groups- half will receive a drain at the time of surgery and the other half will not be receiving a drain.
Detailed Description
The use of closed-suction draining has been well studied in the hip and knee arthroplasty literature. Drains have been used with the intention of decreasing infection, ecchymoses, and frequency of dressing changes. Some have reported a corresponding decrease in hematocrit for patients receiving post-op drainage leading to increased transfusion needs. Given that no clinical benefit has been consistently documented regarding drain usage in knee and hip arthroplasty, they are no longer routinely used in those operations. The use of such drainage systems in shoulder arthroplasty, however, has not been studied and the benefit of drain use in regards to patient outcomes is questionable. As such, the study is a prospective investigation comparing outcomes in two groups of total shoulder arthroplasty patients, those receiving a drain at the time of surgery and those without a drain. The short-term outcome measurements include peri-operative hematocrit and hemoglobin, infection rate, hematoma development, transfusion requirement, ecchymosis and wound complication. Long-term outcomes include shoulder functional scores as measured by post-operative visits and any need for revision shoulder surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TSA with drain placement
Arm Type
Active Comparator
Arm Description
Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
Arm Title
TSA without drain placement
Arm Type
Active Comparator
Arm Description
Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
Intervention Type
Procedure
Intervention Name(s)
Wound drainage
Intervention Description
Experimental portion removing/draining blood/fluid from a space created during a surgical procedure. Typically, surgeons place a plastic tube in the shoulder joint to drain fluids that may accumulate after surgery. Hemovac drain is a FDA-approved device routinely used or wound drainage; however, there is no known evidence whether this improves outcomes of surgery.
Intervention Type
Procedure
Intervention Name(s)
Total Shoulder Arthroplasty
Other Intervention Name(s)
TSA
Intervention Description
Standard procedure for treating the severe pain and stiffness that often result at the end stage of various forms of arthritis or degenerative joint disease of the shoulder joint. The primary goal of shoulder replacement surgery is pain relief, with a secondary benefit of restoring motion, strength, function, and assisting with returning patients to an activity level as near to normal as possible. Shoulder prosthesis is a standard artificial device to replace both components of the "ball and socket" joint during TSA.
Primary Outcome Measure Information:
Title
Change in Hemoglobin level
Description
To assess blood loss
Time Frame
Day 0 post-operative, day 1 post-operative, day 2 post-operative
Title
Change in Hematocrit level
Description
To assess blood loss
Time Frame
Day 0 post-operative, day 1 post-operative, day 2 post-operative
Secondary Outcome Measure Information:
Title
Total length of hospital stay
Description
Calculated in number of days
Time Frame
Day 0 post-operative to discharge, an average of up to 3 days
Title
Total cost incurred during hospital stay
Description
Calculation will include the cost of the surgical procedure
Time Frame
Pre-surgical admitting to discharge, an average of up to 3 days
Title
Change in Elbow Surgeons Evaluation Form (ASES) score
Description
To determine the longterm effect of drain usage on functional shoulder score-total score from 0-100 where 0= worse pain and functional loss /disability
Time Frame
Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative
Title
Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection
Time Frame
Day 0 post-operative to discharge, an average of up to 3 days
Title
Total Drain Output record
Description
Calculated total blood loss in ml
Time Frame
Day 1 post-operative, day 2 post-operative
Title
Number of subjects that presented with anatomic healing after total shoulder arthroplasty
Description
To be determined by shoulder ultrasound results
Time Frame
6 month post-operative, 1 year post-operative, 2 year post-operative
Title
Change in Disabilities of the Arm Shoulder and Hand (DASH) Score
Description
To determine the longterm effect of drain usage on functional shoulder score- measured from 0-100 a higher score indicates greater disability
Time Frame
Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty Exclusion Criteria: Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher S. Ahmad, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Closed Suction Drainage in Shoulder Arthroplasty

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