NCT04810000

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

March 18, 2021

Last Update Submit

March 19, 2021

Conditions

HematomaArthroplasty Complications

Keywords

TourniquetIntra articular HematomaTotal Knee Replacement

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin(HG) drop

    The difference in HG drop

    ( 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

    day three post operative hematoma formation

Study Arms (2)

Group A

Group A ( Tourniquet release before wound closure and hemostasis ensured )

Device: tourniquet

Group B

Group B ( Tourniquet release after wound closure )

Device: tourniquet

Interventions

tourniquetDEVICE

Tourniquet release before/after wound closure

Group AGroup B

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • primary knee osteoarthrosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, 13046, Jordan

Location

MeSH Terms

Conditions

Hematoma

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Yazan S Hammad, MD

    Jordan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator - Senior orthopedic surgery resident

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 22, 2021

Study Start

December 3, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

JO(1)