Arthropathy of HipNCT04333264
Clinical Analysis of Suction Drainage in Cementless Hip Replacement
A study testing suction drainage and no suction drainage in people with Arthropathy of Hip, run by Bartosz Paweł.
Trial summary
Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- suction drainage and no 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
- Mar 2016to Feb 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 30-80
- primary hip osteoarthritis
Who cannot join
- secondary hip osteoarthritis
- autoimmune disease
- congenital or secondary coagulopathy
- vein or artery thrombosis
- renal or liver failure
- cemented or hybrid alloplasty,
- no consent from the patient
About this study
Official title: Clinical Analysis of Suction Drainage in Cementless Hip Replacement - a Prospective Randomized Study
Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.
- Conditions
- Arthropathy of Hip
- Being tested
- suction drainage, no suction drainage
- Keywords
- hip, arthroplasty, suction, drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suction drainageProcedure or surgery
After primary total hip arthroplasty closed suction drainage will be used.
no suction drainageProcedure or surgery
After primary total hip arthroplasty closed suction drainage won't be used.
| Study group | Role | What they receive |
|---|---|---|
| suction drainage | Active comparator | Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty Receives: Procedure: suction drainage |
| no suction drainage | Active comparator | Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty Receives: Procedure: no suction drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip hematoma size in USG
Size in millimeters fluid collection in supine position above femoral neck.
Measured: 3 days after surgery
Hemoglobin levels
Hb levels after surgery, difference between two groups
Measured: 3 days after surgery
C-reactive protein levels
C-reactive protein levels after surgery, difference between two groups
Measured: 3 days after surgery
Visual Analog Scale punctation
Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.
Measured: 3 day after surgery
Hip range of movement
Differences between hip ROM after surgery
Measured: 3 days after surgery
Wound exudation
Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing
Measured: 3 days after surgery
Soft tissue hematoma
USG hematoma appearance in soft tissue around the hip
Measured: 3 days after surgery
Intraoperative bleeding
All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.
Measured: 1 day
Blood transfusion
Need of blood transfusion after operation
Measured: 14 days after surgery
Secondary outcomes (3)
Infection
Superficial or deep infection after surgery
Measured: 30 days after surgery
Deep vein thrombosis
Occurrence lower limb thrombosis after surgery
Measured: 30 days after surgery
Readmission
Need to readmission after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study startMar 2016
- Primary completionJan 2020
- Study completionFeb 2020
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 Arthropathy of 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartosz Paweł
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bartosz Paweł, Prof A Gruca Teaching Hospital
- Investigators
- Pawel Bartosz, Principal investigator, Prof. A. Gruca Teaching Hospital in Otwock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333264
- Sponsor's protocol ID
- 1/032016
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.
PubMed 34389016
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of Suction Drainage in Cementless Hip Replacement - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04333264
- Acronym / sponsor ID
- 1/032016
- Conditions
- Arthropathy of Hip
- Keywords
- hip, arthroplasty, suction, drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bartosz PawełUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 3 Apr 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.
Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
| Arm | Type | Receives |
|---|---|---|
| suction drainage | Active comparator | Procedure: suction drainagePatients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty |
| no suction drainage | Active comparator | Procedure: no suction drainagePatients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 30-80
- primary hip osteoarthritis
Key exclusion criteria (7 listed)
- secondary hip osteoarthritis
- autoimmune disease
- congenital or secondary coagulopathy
- vein or artery thrombosis
- renal or liver failure
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 |
|---|---|---|
| suction drainageAfter primary total hip arthroplasty closed suction drainage will be used. | Procedure or surgery | suction drainage |
| no suction drainageAfter primary total hip arthroplasty closed suction drainage won't be used. | Procedure or surgery | no suction drainage |
Primary outcome
Hip hematoma size in USG
Time frame: 3 days after surgery
Size in millimeters fluid collection in supine position above femoral neck.
Hemoglobin levels
Time frame: 3 days after surgery
Hb levels after surgery, difference between two groups
C-reactive protein levels
Time frame: 3 days after surgery
C-reactive protein levels after surgery, difference between two groups
Visual Analog Scale punctation
Time frame: 3 day after surgery
Pain level after surgery in Visual Analog Scale scale 0-10 pts. where 0-no pain, 10-most painful.
Hip range of movement
Time frame: 3 days after surgery
Differences between hip ROM after surgery
Wound exudation
Time frame: 3 days after surgery
Assessing wound dehiscence after surgery, 1-exudation appear, 0-dry dressing
Soft tissue hematoma
Time frame: 3 days after surgery
USG hematoma appearance in soft tissue around the hip
Intraoperative bleeding
Time frame: 1 day
All amount of blood loss intraoperative with hidden bleeding, with use of Gross formula.
Blood transfusion
Time frame: 14 days after surgery
Need of blood transfusion after operation
3 secondary outcomes
Infection
Time frame: 30 days after surgery
Deep vein thrombosis
Time frame: 30 days after surgery
Readmission
Time frame: 30 days 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 3 Apr 2020.
- Derived from this study: PubMed 34389016Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.
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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
Prof. A. Gruca Teaching Hospital in Otwock
Questions about this trial
What is this clinical trial studying?
A study testing suction drainage and no suction drainage in people with Arthropathy of Hip, run by Bartosz Paweł.
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 7 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 3 Apr 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?
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?
Hip hematoma size in USG (time frame: 3 days after surgery). The study lists 9 primary outcomes in all. 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 NCT04333264, 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 3 Apr 2020.