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NCT Number: NCT02767453

Closed Suction Drainage in Shoulder Arthroplasty

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound drainage

Procedure

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

Procedure

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.

Other names: TSA

Primary outcomes

  1. Change in Hemoglobin level

    Time frame: Day 0 post-operative, day 1 post-operative, day 2 post-operative

    To assess blood loss

  2. Change in Hematocrit level

    Time frame: Day 0 post-operative, day 1 post-operative, day 2 post-operative

    To assess blood loss

Secondary outcomes

  1. Total length of hospital stay

    Time frame: Day 0 post-operative to discharge, an average of up to 3 days

    Calculated in number of days

  2. Total cost incurred during hospital stay

    Time frame: Pre-surgical admitting to discharge, an average of up to 3 days

    Calculation will include the cost of the surgical procedure

  3. Change in Elbow Surgeons Evaluation Form (ASES) score

    Time frame: 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

  4. Number of subjects that developed any of the following: wound compromise, ecchymosis, bleeding, hematoma formation or infection

    Time frame: Day 0 post-operative to discharge, an average of up to 3 days

  5. Total Drain Output record

    Time frame: Day 1 post-operative, day 2 post-operative

    Calculated total blood loss in ml

  6. Number of subjects that presented with anatomic healing after total shoulder arthroplasty

    Time frame: 6 month post-operative, 1 year post-operative, 2 year post-operative

    To be determined by shoulder ultrasound results

  7. Change in Disabilities of the Arm Shoulder and Hand (DASH) Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 10, 2016
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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