OsteoarthritisNCT02767453
Closed Suction Drainage in Shoulder Arthroplasty
A study testing Wound drainage and Total Shoulder Arthroplasty in people with Osteoarthritis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Wound drainage and Total Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 24 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty
Who cannot join
- Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University medical Center
New York, New York, 10032
About this study
Official title: The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.
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.
Read the 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
- Being tested
- Wound drainage, Total Shoulder Arthroplasty
- Keywords
- Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound drainageProcedure or surgery
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 ArthroplastyProcedure or surgery
Also called TSA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Total Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin level
To assess blood loss
Measured: Day 0 post-operative, day 1 post-operative, day 2 post-operative
Change in Hematocrit level
To assess blood loss
Measured: Day 0 post-operative, day 1 post-operative, day 2 post-operative
Secondary outcomes (7)
Total length of hospital stay
Calculated in number of days
Measured: Day 0 post-operative to discharge, an average of up to 3 days
Total cost incurred during hospital stay
Calculation will include the cost of the surgical procedure
Measured: Pre-surgical admitting to discharge, an average of up to 3 days
Change in Elbow Surgeons Evaluation Form (ASES) score
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
Measured: 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
Measured: Day 0 post-operative to discharge, an average of up to 3 days
Total Drain Output record
Calculated total blood loss in ml
Measured: Day 1 post-operative, day 2 post-operative
Number of subjects that presented with anatomic healing after total shoulder arthroplasty
To be determined by shoulder ultrasound results
Measured: 6 month post-operative, 1 year post-operative, 2 year post-operative
Change in Disabilities of the Arm Shoulder and Hand (DASH) Score
To determine the longterm effect of drain usage on functional shoulder score- measured from 0-100 a higher score indicates greater disability
Measured: Baseline, 6 month post-operative, 1 year post-operative, 2 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJan 2015
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher S. Ahmad, MD, Columbia University
- Investigators
- Christopher S. Ahmad, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767453
- Sponsor's protocol ID
- AAAO2805
- Status last verified
- Mar 2019
- First submitted
- 4 May 2016
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Closed Suction Drainage in Total Shoulder Arthroplasty: A Prospective Analysis.
- ClinicalTrials.gov ID
- NCT02767453
- Acronym / sponsor ID
- AAAO2805
- Conditions
- Osteoarthritis
- Keywords
- Shoulder arthroplasty, Closed suction drainage, Glenohumeral, Drainage tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TSA with drain placement | Active comparator | Procedure: Wound drainage, Procedure: Total Shoulder ArthroplastyHemovac drains are placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis. |
| TSA without drain placement | Active comparator | Procedure: Total Shoulder ArthroplastyHemovac drains will not be placed in subjects during standard Total Shoulder Arthroplasty involving the replacement of damaged shoulder components with shoulder prosthesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty
Key exclusion criteria (1 listed)
- Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound drainageExperimental 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. | Procedure or surgery | TSA with drain placement |
| Total Shoulder ArthroplastyAlso: TSAStandard 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. | Procedure or surgery | TSA with drain placement, TSA without drain placement |
Primary outcome
Change in Hemoglobin level
Time frame: Day 0 post-operative, day 1 post-operative, day 2 post-operative
To assess blood loss
Change in Hematocrit level
Time frame: Day 0 post-operative, day 1 post-operative, day 2 post-operative
To assess blood loss
7 secondary outcomes
Total length of hospital stay
Time frame: Day 0 post-operative to discharge, an average of up to 3 days
Total cost incurred during hospital stay
Time frame: Pre-surgical admitting to discharge, an average of up to 3 days
Change in Elbow Surgeons Evaluation Form (ASES) score
Time frame: 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
Time frame: Day 0 post-operative to discharge, an average of up to 3 days
Total Drain Output record
Time frame: Day 1 post-operative, day 2 post-operative
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher S. Ahmad, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound drainage and Total Shoulder Arthroplasty in people with Osteoarthritis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin level (time frame: Day 0 post-operative, day 1 post-operative, day 2 post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.