Clinical trial NCT02767453: Closed Suction Drainage in Shoulder Arthroplasty
Official title: The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Shoulder arthroplasty
Closed suction drainage
Glenohumeral
Drainage tube
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin level
timeFrame: Day 0 post-operative, day 1 post-operative, day 2 post-operative
measure: Change in Hematocrit level
timeFrame: Day 0 post-operative, day 1 post-operative, day 2 post-operative
Secondary outcomes:
measure: Total length of hospital stay
timeFrame: Day 0 post-operative to discharge, an average of up to 3 days
measure: Total cost incurred during hospital stay
timeFrame: Pre-surgical admitting to discharge, an average of up to 3 days
measure: Change in Elbow Surgeons Evaluation Form (ASES) score
timeFrame: Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative
measure: Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection
timeFrame: Day 0 post-operative to discharge, an average of up to 3 days
measure: Total Drain Output record
timeFrame: Day 1 post-operative, day 2 post-operative
measure: Number of subjects that presented with anatomic healing after total shoulder arthroplasty
timeFrame: 6 month post-operative, 1 year post-operative, 2 year post-operative
measure: Change in Disabilities of the Arm Shoulder and Hand (DASH) Score
timeFrame: Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Christopher S. Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References: