Impact of Different Perioperative Tourniquets on Blood Loss and Surgeon Satisfaction in Total Knee Arthroplasty

NCT ID: NCT06947655

Last Updated: 2025-04-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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The present study investigates the impact of two different perioperative tourniquets with different closing features on operative blood los, surgical field quality and surgeon satisfaction.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

The active control group receives a standarized FDA approved perioperative tourniquet (VBM-Tourniquet, VBM Medical, Sulz, Germany).

Group Type ACTIVE_COMPARATOR

VBM Tourniquet

Intervention Type DEVICE

Perioperative VBM-Tourniquet Application with a fixation pressure of 15mmHg.

Intervention Group

The intervention groups receives a standarized, FDA-approved perioperative tourniquet (Adaptive Cuff, Delfi Medical Innovations Inc., Vancouver, Canada).

Group Type EXPERIMENTAL

Adaptive Cuff

Intervention Type DEVICE

Perioperative Delfi-Tourniquet Application with a fixation pressure of 15mmHg.

Interventions

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VBM Tourniquet

Perioperative VBM-Tourniquet Application with a fixation pressure of 15mmHg.

Intervention Type DEVICE

Adaptive Cuff

Perioperative Delfi-Tourniquet Application with a fixation pressure of 15mmHg.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Inidication for a Total Knee Arthroplasty
* Approval for Surgery by the Department of Anesthesia

Exclusion Criteria

* Open Wounds of the lower extremities
* Acute or chronic infections of the lower extremities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Alexander Franz

Dr. med., B.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alexander Franz, Dr. med., B.Sc.

Role: CONTACT

+49 170 3750718

Facility Contacts

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Alexander Franz, B.Sc.

Role: primary

+49 170 3750718

Other Identifiers

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2024_J

Identifier Type: -

Identifier Source: org_study_id

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