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

Completed

• Conditions: Hematoma; Arthroplasty Complications
• Interventions: Device: tourniquet

• Registration Number: NCT04810000
• Lead Sponsor: Yazan Saleh Rajab Hammad

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

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 Timeline

• Study Start: 2018-12-03
• Status Verified: 2021-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-19
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	tourniquet	Group A ( Tourniquet release before wound closure and hemostasis ensured )
Group B	tourniquet	Group B ( Tourniquet release after wound closure )

Primary Outcome Measures

Name	Time	Method
Hemoglobin(HG) drop	( pre-operative and post-operative day 2)	The difference in HG drop
Intra articular Hematoma formation	day three post operative hematoma formation	the difference in Intra articular ( knee ) Hematoma collection between the groups on day 3 post operative

Trial Locations

Locations (1)

The University of Jordan; 🇯🇴 Amman, Jordan