Closed Suction Drainage in Shoulder Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767453
• Other study ID #: AAAO2805
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 24, 2019

Study information

• Verified date: March 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin level	To assess blood loss	Day 0 post-operative, day 1 post-operative, day 2 post-operative
Primary	Change in Hematocrit level	To assess blood loss	Day 0 post-operative, day 1 post-operative, day 2 post-operative
Secondary	Total length of hospital stay	Calculated in number of days	Day 0 post-operative to discharge, an average of up to 3 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Total Drain Output record	Calculated total blood loss in ml	Day 1 post-operative, day 2 post-operative
Secondary	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
Secondary	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