The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication

March 19, 2021 updated by: Yazan Saleh Rajab Hammad

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 13046
        • The University of Jordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • primary knee osteoarthrosis

Exclusion Criteria:

  • Rheumatoid arthritis
  • post traumatic arthritis
  • revision knee replacement
  • patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Group A ( Tourniquet release before wound closure and hemostasis ensured )
Device: tourniquet
Tourniquet release before/after wound closure
Group B
Group B ( Tourniquet release after wound closure )
Device: tourniquet
Tourniquet release before/after wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin(HG) drop
Time Frame: ( pre-operative and post-operative day 2)
The difference in HG drop
( pre-operative and post-operative day 2)
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
day three post operative hematoma formation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yazan Saleh Rajab Hammad

Investigators

  • Principal Investigator: Yazan S Hammad, MD, Jordan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2018

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (ACTUAL)

March 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2018/3489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the measurement of hemoglobin drop and intra articular hematoma measurement by ultrasound

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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