Osteoarthritis, HipNCT02562586
Is Drainage Necessary After Total Hip Replacement?
A study testing Closed Suction Drainage System in people with Osteoarthritis, Hip, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Closed Suction Drainage System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Hip Arthroplasty
- Lateral Hardinge Approach
- Non-cemented Acetabular and Femoral Components
- Length of Skin Incision between 10 and 20 cm
Who cannot join
- Coagulative Disorders
- Previous Surgery in the same limb
- Age below 18 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
São Paulo, São Paulo, 05403-010
About this study
Official title: Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.
Read the detailed description
After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Closed Suction Drainage System
- Keywords
- Suction, Arthroplasty, Replacement, Hip
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Suction Drainage SystemDevice
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Closed Suction Drainage System | Active comparator | Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure Receives: Device: Closed Suction Drainage System |
| No Closed Suction Drainage System | No intervention | Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline red blood cells (RBC)
total RBC loss (mL) = [Uncompensated RBC loss (mL)] + [Compensated RBC loss (mL)] Uncompensated RBC loss (mL) = [Initial RBC (mL)] - [Final RBC (mL)] Compensated RBC loss (mL) = [Sum of RBCs received from the various sources of transfusion] Initial RBC (mL) = [Estimated blood volume (mL)] x [Initial Hct level (%)] at Day -1 Final RBC (mL) = [Estimated blood volume (mL)] x [Final Hct level (%)] at Day +3 Estimated blood volume (mL) = Women: [Body surface area (m2)] x 2430 Men: [Body surface area (m2)] x 2530 Body surface area (m2) = 0.0235 x [Height (cm)]0.42246 x [Weight (kg)]0.51456 Total blood loss at Hct level of 35% (mL) = [Total blood loss (mL)] / 0.35
Measured: Pre-operative and 24 Hours Postoperative
Secondary outcomes (4)
Mid thigh circumference (cm)
Metric tape is placed midway between upper border of patella and superior anterior iliac spine
Measured: Pre-operative and 24 Hours Postoperative to 3 Months Postoperative
C-Reactive Protein (CRP) (mg/L)
Measured: 3,6 and 12 Weeks Postoperative
Erythrocyte sedimentation rate (ESR) (mm/h)
Measured: 3,6 and 12 Weeks Postoperative
Complications
Measured: during 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ricardo Negreiros Vicente, University of Sao Paulo
- Investigators
- Jose Ricardo Negreiros Vicente, MD PhD, Principal investigator, Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562586
- Sponsor's protocol ID
- CEP 1055
- Status last verified
- Sep 2015
- First submitted
- 17 Aug 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou XD, Li J, Xiong Y, Jiang LF, Li WJ, Wu LD. Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop. 2013 Nov;37(11):2109-18. doi: 10.1007/s00264-013-2053-8. Epub 2013 Aug 28.
PubMed 23982636Gonzalez Della Valle A, Slullitel G, Vestri R, Comba F, Buttaro M, Piccaluga F. No need for routine closed suction drainage in elective arthroplasty of the hip: a prospective randomized trial in 104 operations. Acta Orthop Scand. 2004 Feb;75(1):30-3. doi: 10.1080/00016470410001708050.
PubMed 15022802Chen ZY, Gao Y, Chen W, Li X, Zhang YZ. Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2014 Aug;24(6):939-46. doi: 10.1007/s00590-013-1284-0. Epub 2013 Aug 6.
PubMed 23917702Ovadia D, Luger E, Bickels J, Menachem A, Dekel S. Efficacy of closed wound drainage after total joint arthroplasty. A prospective randomized study. J Arthroplasty. 1997 Apr;12(3):317-21. doi: 10.1016/s0883-5403(97)90029-2.
PubMed 9113547Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4.
PubMed 19056215Willett KM, Simmons CD, Bentley G. The effect of suction drains after total hip replacement. J Bone Joint Surg Br. 1988 Aug;70(4):607-10. doi: 10.1302/0301-620X.70B4.3403607.
PubMed 3403607
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02562586
- Acronym / sponsor ID
- CEP 1055
- Conditions
- Osteoarthritis, Hip
- Keywords
- Suction, Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Sep 2015 (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 goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.
Detailed description
After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Suction Drainage System | Active comparator | Device: Closed Suction Drainage SystemGroup 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure |
| No Closed Suction Drainage System | No intervention | –Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Hip Arthroplasty
- Lateral Hardinge Approach
- Non-cemented Acetabular and Femoral Components
- Length of Skin Incision between 10 and 20 cm
Key exclusion criteria (3 listed)
- Coagulative Disorders
- Previous Surgery in the same limb
- Age below 18 years old
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 |
|---|---|---|
| Closed Suction Drainage Systempatients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure | Device | Closed Suction Drainage System |
Primary outcome
Change from baseline red blood cells (RBC)
Time frame: Pre-operative and 24 Hours Postoperative
total RBC loss (mL) = [Uncompensated RBC loss (mL)] + [Compensated RBC loss (mL)] Uncompensated RBC loss (mL) = [Initial RBC (mL)] - [Final RBC (mL)] Compensated RBC loss (mL) = [Sum of RBCs received from the various sources of transfusion] Initial RBC (mL) = [Estimated blood volume (mL)] x [Initial Hct level (%)] at Day -1 Final RBC (mL) = [Estimated blood volume (mL)] x [Final Hct level (%)] at Day +3 Estimated blood volume (mL) = Women: [Body surface area (m2)] x 2430 Men: [Body surface area (m2)] x 2530 Body surface area (m2) = 0.0235 x [Height (cm)]0.42246 x [Weight (kg)]0.51456 Total blood loss at Hct level of 35% (mL) = [Total blood loss (mL)] / 0.35
4 secondary outcomes
Mid thigh circumference (cm)
Time frame: Pre-operative and 24 Hours Postoperative to 3 Months Postoperative
C-Reactive Protein (CRP) (mg/L)
Time frame: 3,6 and 12 Weeks Postoperative
Erythrocyte sedimentation rate (ESR) (mm/h)
Time frame: 3,6 and 12 Weeks Postoperative
Complications
Time frame: during 3 months follow-up
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 29 Sep 2015.
- Background: PubMed 23982636Zhou XD, Li J, Xiong Y, Jiang LF, Li WJ, Wu LD. Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop. 2013 Nov;37(11):2109-18. doi: 10.1007/s00264-013-2053-8. Epub 2013 Aug 28.
- Background: PubMed 15022802Gonzalez Della Valle A, Slullitel G, Vestri R, Comba F, Buttaro M, Piccaluga F. No need for routine closed suction drainage in elective arthroplasty of the hip: a prospective randomized trial in 104 operations. Acta Orthop Scand. 2004 Feb;75(1):30-3. doi: 10.1080/00016470410001708050.
- Background: PubMed 23917702Chen ZY, Gao Y, Chen W, Li X, Zhang YZ. Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2014 Aug;24(6):939-46. doi: 10.1007/s00590-013-1284-0. Epub 2013 Aug 6.
- Background: PubMed 9113547Ovadia D, Luger E, Bickels J, Menachem A, Dekel S. Efficacy of closed wound drainage after total joint arthroplasty. A prospective randomized study. J Arthroplasty. 1997 Apr;12(3):317-21. doi: 10.1016/s0883-5403(97)90029-2.
- Background: PubMed 19056215Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4.
- Background: PubMed 3403607Willett KM, Simmons CD, Bentley G. The effect of suction drains after total hip replacement. J Bone Joint Surg Br. 1988 Aug;70(4):607-10. doi: 10.1302/0301-620X.70B4.3403607.
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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.
Jose Ricardo Negreiros Vicente, MD PhD principal investigator
Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Suction Drainage System in people with Osteoarthritis, Hip, run by University of Sao Paulo at 1 site in Brazil.
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: finished, as of the sponsor's last update on 29 Sep 2015. 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 Brazil. 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 from baseline red blood cells (RBC) (time frame: Pre-operative and 24 Hours Postoperative). 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 NCT02562586, which also lists 6 linked publications.
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 29 Sep 2015.