Closed Suction Drainage in Shoulder Arthroplasty

Not Applicable

Completed

Interventions: Procedure: Wound drainage
Procedure: Total Shoulder Arthroplasty

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
TSA with drain placement	Total Shoulder Arthroplasty	Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
TSA with drain placement	Wound drainage	Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.
TSA without drain placement	Total Shoulder Arthroplasty	Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin level	Day 0 post-operative, day 1 post-operative, day 2 post-operative	To assess blood loss
Change in Hematocrit level	Day 0 post-operative, day 1 post-operative, day 2 post-operative	To assess blood loss

Secondary Outcome Measures

Name	Time	Method
Total length of hospital stay	Day 0 post-operative to discharge, an average of up to 3 days	Calculated in number of days
Total cost incurred during hospital stay	Pre-surgical admitting to discharge, an average of up to 3 days	Calculation will include the cost of the surgical procedure
Change in Elbow Surgeons Evaluation Form (ASES) score	Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative	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	Day 0 post-operative to discharge, an average of up to 3 days
Total Drain Output record	Day 1 post-operative, day 2 post-operative	Calculated total blood loss in ml
Number of subjects that presented with anatomic healing after total shoulder arthroplasty	6 month post-operative, 1 year post-operative, 2 year post-operative	To be determined by shoulder ultrasound results
Change in Disabilities of the Arm Shoulder and Hand (DASH) Score	Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative	To determine the longterm effect of drain usage on functional shoulder score- measured from 0-100 a higher score indicates greater disability

Locations (1): Columbia University medical Center
🇺🇸
New York, New York, United States