Closed Suction Drainage in Shoulder Arthroplasty

NCT ID: NCT02767453

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-24

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TSA with drain placement

Hemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.

Group Type: ACTIVE_COMPARATOR

Wound drainage

Intervention Type: 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

Intervention Type: 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.

TSA without drain placement

Hemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis.

Group Type: ACTIVE_COMPARATOR

Total Shoulder Arthroplasty

Intervention Type: 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.

Interventions

Wound 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.

Intervention Type: PROCEDURE

Total 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.

Intervention Type: PROCEDURE

Other Intervention Names

TSA

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Christopher S. Ahmad, MD

Professor of Orthopedic Surgery at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher S. Ahmad, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAO2805

Identifier Type: -

Identifier Source: org_study_id