Hip OsteoarthritisNCT04486040
Closed Suction Drainage After Revision Hip Arthroplasty
A study testing Drainage and No-drainage in people with Hip Osteoarthritis and Bleeding, run by Prof A Gruca Teaching Hospital.
Trial summary
Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Bleeding
- What is being tested?
- Drainage and No-drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2016to 13 Mar 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aseptic loosening,
- head or insert damage,
- girdlestone hip
Who cannot join
- septic loosening,
- primary or secondary coagulopathy,
- renal or hepatic failure,
- thromboembolism in past history
About this study
Official title: Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study
Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.
Read the detailed description
Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.
- Conditions
- Hip Osteoarthritis, Bleeding
- Being tested
- Drainage, No-drainage
- Keywords
- Hip, Revision, Arthroplasty, Drainage
- Medical subject headings
- Osteoarthritis, Hip, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainageProcedure or surgery
Use of the suction drainage after hip revision arthroplasty
No-drainageProcedure or surgery
Patients without drainage after surgery
| Study group | Role | What they receive |
|---|---|---|
| Drainage group | Active comparator | Patients with drainage after hip revision arthroplasty Receives: Procedure: Drainage |
| No-drainage group | Active comparator | Patients without drainage after hip revision arthroplasty Receives: Procedure: No-drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma size
Level of fluid at endoprosthesis neck in ultrasonography
Measured: 3 days after surgery
Hemoglobin level
Hemoglobin level after surgery on 1st and 3rd day after surgery
Measured: 3 days after surgery
Blood loss
Assessing blood loss with use of Gross formula
Measured: 1 day after surgery
Reinfection
Number of patients with infection after surgery performed in the study
Measured: 2 years after surgery
Secondary outcomes (5)
Soft tissue hematoma
Note hematoma formation in soft tissue after surgery (ultrasonography)
Measured: 3 days after surgery
C-reactive protein level
Level of C-reactive protein after surgery
Measured: 3 days after surgery
Blood transfusion
Number of patients who need blood transfusion after surgery
Measured: 5-14 days after surgery
Visual Analog Scale
Level of pain after surgery, 1- no pain; 10- "the worst pain you ever had"
Measured: 3 days after surgery
Harris Hip Score
Clinical outcome after surgery, 0-100 points; 100 points the best score
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start14 Mar 2016
- Primary completion13 Mar 2018
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof A Gruca Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Paweł, Prof A Gruca Teaching Hospital
- Investigators
- Pawel Bartosz, Principal investigator, Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486040
- Sponsor's protocol ID
- GrucaTH
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2020
- Last updated
- 9 Aug 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04486040
- Acronym / sponsor ID
- GrucaTH
- Conditions
- Hip Osteoarthritis, Bleeding
- Keywords
- Hip, Revision, Arthroplasty, Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Prof A Gruca Teaching HospitalUniversity, hospital or other
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 24 Jul 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.
Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.
Detailed description
Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainage group | Active comparator | Procedure: DrainagePatients with drainage after hip revision arthroplasty |
| No-drainage group | Active comparator | Procedure: No-drainagePatients without drainage after hip revision arthroplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aseptic loosening,
- head or insert damage,
- girdlestone hip
Key exclusion criteria (4 listed)
- septic loosening,
- primary or secondary coagulopathy,
- renal or hepatic failure,
- thromboembolism in past history
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 |
|---|---|---|
| DrainageUse of the suction drainage after hip revision arthroplasty | Procedure or surgery | Drainage group |
| No-drainagePatients without drainage after surgery | Procedure or surgery | No-drainage group |
Primary outcome
Hematoma size
Time frame: 3 days after surgery
Level of fluid at endoprosthesis neck in ultrasonography
Hemoglobin level
Time frame: 3 days after surgery
Hemoglobin level after surgery on 1st and 3rd day after surgery
Blood loss
Time frame: 1 day after surgery
Assessing blood loss with use of Gross formula
Reinfection
Time frame: 2 years after surgery
Number of patients with infection after surgery performed in the study
5 secondary outcomes
Soft tissue hematoma
Time frame: 3 days after surgery
C-reactive protein level
Time frame: 3 days after surgery
Blood transfusion
Time frame: 5-14 days after surgery
Visual Analog Scale
Time frame: 3 days after surgery
Harris Hip Score
Time frame: 6 weeks after surgery
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 9 Aug 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.
Pawel Bartosz principal investigator
Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock
Questions about this trial
What is this clinical trial studying?
A study testing Drainage and No-drainage in people with Hip Osteoarthritis and Bleeding, run by Prof A Gruca Teaching Hospital.
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 3 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: finished, as of the sponsor's last update on 9 Aug 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?
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?
Hematoma size (time frame: 3 days after surgery). The study lists 4 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 9 Aug 2021; AzTrials last refreshed its copy on 2 Nov 2026.