Closed Suction Drainage in Shoulder Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Wound drainage
* Procedure: Total Shoulder Arthroplasty


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TSA with drain placement<br>Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis. | Procedure: Wound drainage<br>* 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.<br>Procedure: Total Shoulder Arthroplasty<br>* 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.<br>* Other names: TSA;|
| Active Comparator: TSA without drain placement<br>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<br>* 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.<br>* Other names: TSA;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube