HematomaNCT04810000
The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication
An observational study of Hematoma and Arthroplasty Complications, run by Yazan Saleh Rajab Hammad at 1 site in Jordan.
Trial summary
The study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematoma, Arthroplasty Complications
- What is being tested?
- tourniquet
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 1 siteJordan
- Study dates
- 3 Dec 2018to 1 Mar 2021
- How long will I take part?
- 3 Years
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study was conducted in University hospital in the Capital city , the patients were from all around the country - Jordan - , as the hospital is as tertiary hospital most of the patients were above 60 , mostly female
Who may be able to join
- primary knee osteoarthrosis
Who cannot join
- Rheumatoid arthritis
- post traumatic arthritis
- revision knee replacement
- patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg
Trial locations and contacts
1 site in 1 country.
About this study
The study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure
The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication
Read the detailed description
The study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period.
the patient randomly assigned to either group A (Tourniquet release before closure of the wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure )
post operative Hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . The wound complication between the groups was also studied .
- Conditions
- Hematoma, Arthroplasty Complications
- Being tested
- tourniquet
- Keywords
- Tourniquet, Intra articular Hematoma, Total Knee Replacement
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquetDevice
Tourniquet release before/after wound closure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A ( Tourniquet release before wound closure and hemostasis ensured ) Receives: Device: tourniquet | |
| Group B | Group B ( Tourniquet release after wound closure ) Receives: Device: tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin(HG) drop
The difference in HG drop
Measured: ( pre-operative and post-operative day 2)
Intra articular Hematoma formation
the difference in Intra articular ( knee ) Hematoma collection between the groups on day 3 post operative
Measured: day three post operative hematoma formation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start3 Dec 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Yazan Saleh Rajab Hammad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yazan Saleh Rajab Hammad, University of Jordan
- Investigators
- Yazan S Hammad, MD, Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810000
- Sponsor's protocol ID
- 10/2018/3489
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: the measurement of hemoglobin drop and intra articular hematoma measurement by ultrasound
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication
- ClinicalTrials.gov ID
- NCT04810000
- Acronym / sponsor ID
- 10/2018/3489
- Conditions
- Hematoma, Arthroplasty Complications
- Keywords
- Tourniquet, Intra articular Hematoma, Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Yazan Saleh Rajab HammadUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Mar 2021 (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 study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure
The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication
Detailed description
The study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period.
the patient randomly assigned to either group A (Tourniquet release before closure of the wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure )
post operative Hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . The wound complication between the groups was also studied .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: tourniquetGroup A ( Tourniquet release before wound closure and hemostasis ensured ) |
| Group B | – | Device: tourniquetGroup B ( Tourniquet release after wound closure ) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study was conducted in University hospital in the Capital city , the patients were from all around the country - Jordan - , as the hospital is as tertiary hospital most of the patients were above 60 , mostly female
Key inclusion criteria (1 listed)
- primary knee osteoarthrosis
Key exclusion criteria (4 listed)
- Rheumatoid arthritis
- post traumatic arthritis
- revision knee replacement
- patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg
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 |
|---|---|---|
| tourniquetTourniquet release before/after wound closure | Device | Group A, Group B |
Primary outcome
Hemoglobin(HG) drop
Time frame: ( pre-operative and post-operative day 2)
The difference in HG drop
Intra articular Hematoma formation
Time frame: day three post operative hematoma formation
the difference in Intra articular ( knee ) Hematoma collection between the groups on day 3 post operative
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 23 Mar 2021.
- Individual participant dataSharing planned: Undecided. the measurement of hemoglobin drop and intra articular hematoma measurement by ultrasound
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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.
Yazan S Hammad, MD principal investigator
Jordan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma and Arthroplasty Complications, run by Yazan Saleh Rajab Hammad at 1 site in Jordan.
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 1 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 23 Mar 2021. 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 Jordan. 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?
Hemoglobin(HG) drop (time frame: ( pre-operative and post-operative day 2)). The study lists 2 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 23 Mar 2021.