Blood Loss, SurgicalNCT04508101
Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty
An observational study of Blood Loss, Surgical, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Loss, Surgical
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2020to 4 Sep 2020
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected from knee osteoarthritis with total as well as unicompartmental knee arthroplasty indication.
Who may be able to join
- knee osteoarthritis diagnosis
- No contraindications to antithrombotic prophylaxis
- Availability of blood tests results before surgery as well as in the first three postoperative days.
- Detailed description of clinical records
Who cannot join
- contraindications to antithrombotic prophylaxis
- anti-platelet therapy
- knee arthroplasty revision indication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty: a Comparative Retrospective Study
Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. In fact, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Furthermore, the drain itself could interfere with knee mobilization, delaying its functional recovery. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of total as well as unicompartmental knee arthroplasty.
Read the detailed description
Knee arthroplasty is currently a widespread treatment either for osteoarthritis (OA) as well as other joint disorders. Specifically, total knee arthroplasty (TKA) is commonly considered one of the most effective orthopedic procedure in the treatment of end-stage knee OA as well as various rheumatic diseases such as rheumatoid arthritis, leading to a substantial pain relief and functional improvement. Besides, unicompartmental knee arthroplasty (UKA) represents a viable alternative in the treatment of unicompartmental knee OA showing a lower morbidity. Nevertheless, since knee arthroplasty involves soft tissue dissections and numerous bone cuts, several perioperative complications can be observed. Particularly, the subsequent local hemorrhage can lead to anemia, functional limitation, nerve palsy as well as increase in wound tension resulting in healing impairment. Moreover, the local hematoma could represent a growth environment for bacteria. Although TKA usually shows a higher hemorrhage rate, some patients undergoing UKA still show the aforementioned complications. Accordingly, intraarticular suction drainage placement can likely ease the hematoma drain, leading to swelling decrease, surgical wound healing improvement as well as reduction of postoperative infections. However, despite suction drainage is routinely used in TKA as well as UKA, there are still no precise guidelines and its effectiveness remains controversial. Indeed, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Moreover, the drainage conduit could obstruct physiotherapy leading to a delayed recovery. Therefore, since fast-track program has been increasingly applied in the management of TKA and UKA, an early drainage removal is recommended. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of TKA and UKA.
- Conditions
- Blood Loss, Surgical
- Keywords
- suction drainage, total knee arthtoplasty, unicompartmental knee arthroplasty
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| drainage group | Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty with suction drainage positioning | |
| non-drainage group | Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty without suction drainage positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin trend
Hemoglobin values comparison between the two groups
Measured: 4 days
Secondary outcomes (3)
Knee swelling
Evaluation of knee swelling during hospitalization (knee circumference variation > 2 cm)
Measured: 5 days
Wound bleeding
Evaluation of wound bleeding during hospitalization (number of dressing changed)
Measured: 5 days
Need for transfusion
Evaluation of transfusion rate during hospitalization (number of transfusions preformed)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start7 Aug 2020 (estimated)
- Primary completion24 Aug 2020 (estimated)
- Study completion4 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiana Balbino, MD, Principal investigator, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508101
- Sponsor's protocol ID
- DRGIN1
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manta N, Mangiavini L, Balbino C, Colombo A, Pandini EG, Pironti P, Vigano M, D'Anchise R. The role of suction drainage in the management of peri-operative bleeding in Total and Unicomcompartmental knee arthroplasty: a retrospective comparative study. BMC Musculoskelet Disord. 2021 Dec 10;22(1):1031. doi: 10.1186/s12891-021-04868-4.
PubMed 34893042
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty: a Comparative Retrospective Study
- ClinicalTrials.gov ID
- NCT04508101
- Acronym / sponsor ID
- DRGIN1
- Conditions
- Blood Loss, Surgical
- Keywords
- suction drainage, total knee arthtoplasty, unicompartmental knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 7 Aug 2020 (estimated)
- Primary completion
- 24 Aug 2020 (estimated)
- Study completion
- 4 Sep 2020 (estimated)
- First posted
- 11 Aug 2020 (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.
Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. In fact, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Furthermore, the drain itself could interfere with knee mobilization, delaying its functional recovery. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of total as well as unicompartmental knee arthroplasty.
Detailed description
Knee arthroplasty is currently a widespread treatment either for osteoarthritis (OA) as well as other joint disorders. Specifically, total knee arthroplasty (TKA) is commonly considered one of the most effective orthopedic procedure in the treatment of end-stage knee OA as well as various rheumatic diseases such as rheumatoid arthritis, leading to a substantial pain relief and functional improvement. Besides, unicompartmental knee arthroplasty (UKA) represents a viable alternative in the treatment of unicompartmental knee OA showing a lower morbidity. Nevertheless, since knee arthroplasty involves soft tissue dissections and numerous bone cuts, several perioperative complications can be observed. Particularly, the subsequent local hemorrhage can lead to anemia, functional limitation, nerve palsy as well as increase in wound tension resulting in healing impairment. Moreover, the local hematoma could represent a growth environment for bacteria. Although TKA usually shows a higher hemorrhage rate, some patients undergoing UKA still show the aforementioned complications. Accordingly, intraarticular suction drainage placement can likely ease the hematoma drain, leading to swelling decrease, surgical wound healing improvement as well as reduction of postoperative infections. However, despite suction drainage is routinely used in TKA as well as UKA, there are still no precise guidelines and its effectiveness remains controversial. Indeed, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Moreover, the drainage conduit could obstruct physiotherapy leading to a delayed recovery. Therefore, since fast-track program has been increasingly applied in the management of TKA and UKA, an early drainage removal is recommended. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of TKA and UKA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drainage group | – | –Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty with suction drainage positioning |
| non-drainage group | – | –Patients satisfying inclusion criteria who underwent either total as well as unicompartmental knee arthroplasty without suction drainage positioning |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected from knee osteoarthritis with total as well as unicompartmental knee arthroplasty indication.
Key inclusion criteria (4 listed)
- knee osteoarthritis diagnosis
- No contraindications to antithrombotic prophylaxis
- Availability of blood tests results before surgery as well as in the first three postoperative days.
- Detailed description of clinical records
Key exclusion criteria (3 listed)
- contraindications to antithrombotic prophylaxis
- anti-platelet therapy
- knee arthroplasty revision indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin trend
Time frame: 4 days
Hemoglobin values comparison between the two groups
3 secondary outcomes
Knee swelling
Time frame: 5 days
Wound bleeding
Time frame: 5 days
Need for transfusion
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 34893042Manta N, Mangiavini L, Balbino C, Colombo A, Pandini EG, Pironti P, Vigano M, D'Anchise R. The role of suction drainage in the management of peri-operative bleeding in Total and Unicomcompartmental knee arthroplasty: a retrospective comparative study. BMC Musculoskelet Disord. 2021 Dec 10;22(1):1031. doi: 10.1186/s12891-021-04868-4.
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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.
Cristiana Balbino, MD principal investigator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Surgical, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 4 inclusion and 3 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 11 Aug 2020. 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 PIERLUIGI PIRONTI, MD (+39 3385362097, pierluigi.pironti@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin trend (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508101, which also lists 1 linked publication.
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 11 Aug 2020.