Osteoarthritis
Conditions
Keywords
Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube
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.
Interventions
PROCEDUREWound 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.
PROCEDURETotal 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.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 length of hospital stay | Day 0 post-operative to discharge, an average of up to 3 days | Calculated in number of days |
| 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 |
| Total Drain Output record | Day 1 post-operative, day 2 post-operative | Calculated total blood loss in ml |
| 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 |
Countries
United States
Outcome results
None listed