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Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

NCT ID: NCT03942939

Last Updated: 2020-11-04

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-27

Study Completion Date

2020-07-15

Brief Summary

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The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time.

Detailed Description

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The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time. The primary objectives will be to compare the total duration of hospital stay, quadriceps function, and the amount of postoperative narcotics utilized and VAS pain levels. The secondary objective will be to compare variables of patient functionality at five postoperative intervals.

Conditions

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Knee Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A - TKA with short tourniquet time

50 arms: subjects will receive a tourniquet with a short tourniquet time during TKA surgery. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.

Group Type EXPERIMENTAL

Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time

Intervention Type OTHER

Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.

B - TKA with tourniquet

50 arms: subjects will receive a tourniquet during TKA surgery.

Group Type ACTIVE_COMPARATOR

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Intervention Type OTHER

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Interventions

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Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time

Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.

Intervention Type OTHER

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient is over the age of 21
2. Patient is scheduled to undergo a unilateral, cementless primary RA-TKA, secondary to osteoarthritis
3. Surgical approach is subvastus approach
4. Patient's BMI (body mass index) is less than 40 at time of surgery.
5. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
6. Patient is able to read and speak English

Exclusion Criteria

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)
3. Patient is scheduled to undergo a bilateral TKA surgery
4. Patient BMI is \> 40
5. Patient is unable to read and speak English
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Arthur Malkani

Professor, Adult Reconstruction

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur L Malkani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Jewish Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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19.0365

Identifier Type: -

Identifier Source: org_study_id