Closed Suction Drainage in Shoulder Arthroplasty

The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Wound drainage; Procedure: Total Shoulder Arthroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TSA with drain placement; Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.	Procedure: Wound drainage; 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.; Procedure: Total Shoulder Arthroplasty; 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.; Other Names: TSA
ACTIVE_COMPARATOR: TSA without drain placement; Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.	Procedure: Total Shoulder Arthroplasty; 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.; Other Names: TSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin level	To assess blood loss	Day 0 post-operative, day 1 post-operative, day 2 post-operative
Change in Hematocrit level	To assess blood loss	Day 0 post-operative, day 1 post-operative, day 2 post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total length of hospital stay	Calculated in number of days	Day 0 post-operative to discharge, an average of up to 3 days
Total cost incurred during hospital stay	Calculation will include the cost of the surgical procedure	Pre-surgical admitting to discharge, an average of up to 3 days
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	Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative
Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection		Day 0 post-operative to discharge, an average of up to 3 days
Total Drain Output record	Calculated total blood loss in ml	Day 1 post-operative, day 2 post-operative
Number of subjects that presented with anatomic healing after total shoulder arthroplasty	To be determined by shoulder ultrasound results	6 month post-operative, 1 year post-operative, 2 year post-operative
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	Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Christopher S. Ahmad, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): January 24, 2019
• Study Completion (ACTUAL): January 24, 2019

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Shoulder arthroplasty; Closed suction drainage; Glenohumeral; Drainage tube
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: AAAO2805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No