Impact of Different Perioperative Tourniquets on Blood Lo... | NCT06947655

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

NCT06947655

Sponsor

University Hospital, Bonn

Status

Recruiting

Last Update Posted

Apr 27, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Total Knee Arthroplasty

Interventions

VBM Tourniquet
Adaptive Cuff

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 20, 2025

First Submission Date that Met QC Criteria

Apr 20, 2025

First Posted Date

Apr 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2025

Last Update Posted Date

Apr 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	The active control group receives a standarized FDA approved perioperative tourniquet (VBM-Tourniquet, VBM Medical, Sulz, Germany).	Device: VBM Tourniquet
Intervention Group	Experimental	The intervention groups receives a standarized, FDA-approved perioperative tourniquet (Adaptive Cuff, Delfi Medical Innovations Inc., Vancouver, Canada).	Device: Adaptive Cuff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VBM Tourniquet	Device	Perioperative VBM-Tourniquet Application with a fixation pressure of 15mmHg.	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Loss	Perioperative blood loss in ml.	Perioperative
Surgeon Satisfaction	Surgical Satisfaction on a 0-100 mm VAS	Perioperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Franz, Dr. med., B.Sc.	Contact	+49 170 3750718		alexander.franz@ukbonn.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bonn	Recruiting	Bonn	North Rhine-Westphalia	53127	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided