After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

NCT ID: NCT03795805

Last Updated: 2019-01-09

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2018-12-20

Brief Summary

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This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Detailed Description

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This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Conditions

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Arthroplasty, Replacement, Knee Acute Kidney Injury Tourniquets Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TKA and Tourniquet

Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg

Group Type OTHER

total knee arthroplasty

Intervention Type PROCEDURE

Total knee arhroplasty

Tourniquet limb cuff

Intervention Type PROCEDURE

Tourniquet limb cuff and regular anesthesia

Intraarticular lidocain

Total knee arthroplasty with Intaarticular lidocain

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type PROCEDURE

Total knee arhroplasty

Intaarticular lidocain

Intervention Type DRUG

20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)

Interventions

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total knee arthroplasty

Total knee arhroplasty

Intervention Type PROCEDURE

Tourniquet limb cuff

Tourniquet limb cuff and regular anesthesia

Intervention Type PROCEDURE

Intaarticular lidocain

20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)

Intervention Type DRUG

Other Intervention Names

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TKA lidocaine

Eligibility Criteria

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Inclusion Criteria

* Patients knee arthrosis
* Required a surgical treatment with Total Knee Arthroplasty

Exclusion Criteria

* Not accept to be in the study
* Not signed consent form
* Not having blood sample for creatinin meassure
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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JUAN LOPEZ VALENCIA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avelino Colin Vázquez, MD

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

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UMAE Dr. Victorio de La Fuente Narvaez

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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R-2018-3401-053

Identifier Type: -

Identifier Source: org_study_id

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