Closed Suction Drainage in Shoulder Arthroplasty

NCT02767453 | Completed

• 1 other identifier: AAAO2805
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Shoulder arthroplasty; Closed suction drainage; Glenohumeral; Drainage tube

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Total length of hospital stay

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

• Total cost incurred during hospital stay

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

• Change in Elbow Surgeons Evaluation Form (ASES) score

  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

  Day 1 post-operative, day 2 post-operative

Study Arms (2)

TSA with drain placement

ACTIVE COMPARATOR

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

Procedure: Wound drainage; Procedure: Total Shoulder Arthroplasty

TSA without drain placement

ACTIVE COMPARATOR

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

Interventions

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.

TSA with drain placement

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.

Also known as: TSA

TSA with drain placement; TSA without drain placement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty

You may not qualify if:

• Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Shoulder; theasinensin A

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Christopher S. Ahmad, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Surgery at the Columbia University Medical Center

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 10, 2016
• Study Start: January 1, 2015
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)