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NCT04810000 Clinical Trial

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

Arthroplasty Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04810000
Other study ID # 10/2018/3489
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 3, 2018
Est. completion date March 1, 2021

Study information
Verified date March 2021
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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

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 .

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• tourniquet
Tourniquet release before/after wound closure

Locations
Country Name City State
Jordan The University of Jordan Amman

Sponsors (1)
Lead Sponsor Collaborator
Yazan Saleh Rajab Hammad

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin(HG) drop The difference in HG drop ( pre-operative and post-operative day 2)
Primary 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
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