Total Knee ReplacementTKRNCT03995160
Influence of Closed Suction Drainage After Total Knee Replacement.
A study testing Use of closed suction drainage following total knee arthroplasty and Abstain of using a closed suction drainage in people with Total Knee Replacement, run by Medical University of Warsaw.
Trial summary
The aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Use of closed suction drainage following total knee arthroplasty and Abstain of using a closed suction drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient's consent for anticipation in the study
- arthroplasty in one knee
Who cannot join
- patient's lack of consent for anticipation in the study
- haematological diseases
- reoperations in the area of endoprosthesis
- medical history of any surgical intervention on the lower limb
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors
The aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Use of closed suction drainage may have influence on patients functional outcome.
Read the detailed description
Patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. Subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively.
Change in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets.
Change in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital.
Change in levels of inflammation factors will be measured by analyzing the level of C-reactive protein in first and third day postoperatively.
Change in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital
Presence of haematoma will be evaluated daily in the postoperative period by clinical examination.
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Costs of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups
- Conditions
- Total Knee Replacement
- Being tested
- Use of closed suction drainage following total knee arthroplasty, Abstain of using a closed suction drainage
- Keywords
- total, knee, arthroplasty, tkr, drainage, haematoma
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of closed suction drainage following total knee arthroplastyProcedure or surgery
Also called Redon's drain
Use of closed suction drainage following total knee arthroplasty
Abstain of using a closed suction drainageProcedure or surgery
Abstain of using a closed suction drainage following total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Total knee replacement with use of closed suction drainage | Active comparator | Use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis Receives: Procedure: Use of closed suction drainage following total knee arthroplasty |
| Total knee replacement without use of closed suction drainage | Active comparator | Without the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis Receives: Procedure: Abstain of using a closed suction drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haematocrite levels
Measuring results of haematocrite (in percentage in 1 ml of blood sample)
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Change in the number of blood transfusions
Measuring the number of needed transfusion of packed red blood cells in the postoperative period
Measured: from baseline to the 1-,2-,3- days postoperatively
Change in levels of inflammation factors
Measuring the level of C-reactive protein
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Change in haemoglobin levels
Measuring results of haemoglobin (g/dL)
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Change in erythrocytes levels
Measuring results of erythrocytes (number/ml)
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Change in platelets levels
Measuring results of platelets (number/ml)
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Secondary outcomes (4)
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline
The WOMAC Pain score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Pain scores range from 0-100 with lower scores considered lower pain.
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline
The WOMAC Function score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Function scores range from 0-100 with lower scores considered to have better function.
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in body temperature
Measuring body temperature from day of the surgery to the hospital until the day of discharge from the hospital
Measured: from baseline to the 1-,2-,3- days postoperatively
Influence of using CSD on costs of hospitalization
Comparing cost of hospitalization between two analyzed groups
Measured: from baseline to the one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Mar 2022 (estimated)
- Primary completion2 Nov 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Artur Stolarczyk, MD, PhD, Study director, Medical University of WarsawMarcin Wojewodzki, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995160
- Sponsor's protocol ID
- TKR/ Warsaw MU
- Acronym
- TKR
- Status last verified
- Oct 2021
- First submitted
- 25 Apr 2019
- Last updated
- 6 Oct 2021
- 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 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors
- ClinicalTrials.gov ID
- NCT03995160
- Acronym / sponsor ID
- TKR / TKR/ Warsaw MU
- Conditions
- Total Knee Replacement
- Keywords
- total, knee, arthroplasty, tkr, drainage, haematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 2 Nov 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 Jun 2019 (actual)
- 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 aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Use of closed suction drainage may have influence on patients functional outcome.
Detailed description
Patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. Subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively.
Change in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets.
Change in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital.
Change in levels of inflammation factors will be measured by analyzing the level of C-reactive protein in first and third day postoperatively.
Change in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital
Presence of haematoma will be evaluated daily in the postoperative period by clinical examination.
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Costs of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee replacement with use of closed suction drainage | Active comparator | Procedure: Use of closed suction drainage following total knee arthroplastyUse of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis |
| Total knee replacement without use of closed suction drainage | Active comparator | Procedure: Abstain of using a closed suction drainageWithout the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient's consent for anticipation in the study
- arthroplasty in one knee
Key exclusion criteria (4 listed)
- patient's lack of consent for anticipation in the study
- haematological diseases
- reoperations in the area of endoprosthesis
- medical history of any surgical intervention on the lower limb
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 |
|---|---|---|
| Use of closed suction drainage following total knee arthroplastyAlso: Redon's drainUse of closed suction drainage following total knee arthroplasty | Procedure or surgery | Total knee replacement with use of closed suction drainage |
| Abstain of using a closed suction drainageAbstain of using a closed suction drainage following total knee arthroplasty | Procedure or surgery | Total knee replacement without use of closed suction drainage |
Primary outcome
Change in haematocrite levels
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Measuring results of haematocrite (in percentage in 1 ml of blood sample)
Change in the number of blood transfusions
Time frame: from baseline to the 1-,2-,3- days postoperatively
Measuring the number of needed transfusion of packed red blood cells in the postoperative period
Change in levels of inflammation factors
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Measuring the level of C-reactive protein
Change in haemoglobin levels
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Measuring results of haemoglobin (g/dL)
Change in erythrocytes levels
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Measuring results of erythrocytes (number/ml)
Change in platelets levels
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
Measuring results of platelets (number/ml)
4 secondary outcomes
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in body temperature
Time frame: from baseline to the 1-,2-,3- days postoperatively
Influence of using CSD on costs of hospitalization
Time frame: from baseline to the one year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- 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.
Artur Stolarczyk, MD, PhD study director
Medical University of Warsaw
Marcin Wojewodzki principal investigator
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
A study testing Use of closed suction drainage following total knee arthroplasty and Abstain of using a closed suction drainage in people with Total Knee Replacement, run by Medical University of Warsaw.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Maciąg (+48 881568144, bartosz.maciag94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in haematocrite levels (time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively). The study lists 6 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 6 Oct 2021.