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Completed

NCT Number: NCT04810000

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

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

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Key information

Conditions

Hematoma Arthroplasty Complications Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Jordan

Amman, 13046, Jordan

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tourniquet

Device

Tourniquet release before/after wound closure

Primary outcomes

  1. Hemoglobin(HG) drop

    Time frame: ( pre-operative and post-operative day 2)

    The difference in HG drop

  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

Sponsors and collaborators

Lead sponsor

Yazan Saleh Rajab Hammad

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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