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

NCT ID: NCT04810000

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-03

Study Completion Date

2021-03-01

Brief Summary

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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

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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 .

Conditions

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Hematoma Arthroplasty Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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

tourniquet

Intervention Type DEVICE

Tourniquet release before/after wound closure

Group B

Group B ( Tourniquet release after wound closure )

tourniquet

Intervention Type DEVICE

Tourniquet release before/after wound closure

Interventions

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tourniquet

Tourniquet release before/after wound closure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yazan Saleh Rajab Hammad

OTHER

Sponsor Role lead

Responsible Party

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Yazan Saleh Rajab Hammad

Sponsor-Investigator - Senior orthopedic surgery resident

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yazan S Hammad, MD

Role: PRINCIPAL_INVESTIGATOR

Jordan University Hospital

Locations

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The University of Jordan

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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10/2018/3489

Identifier Type: -

Identifier Source: org_study_id

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