NCT06947655

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Blood Loss

    Perioperative blood loss in ml.

    Perioperative

  • Surgeon Satisfaction

    Surgical Satisfaction on a 0-100 mm VAS

    Perioperative

Study Arms (2)

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

VBM TourniquetDEVICE

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

Control
Adaptive CuffDEVICE

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

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Open Wounds of the lower extremities
  • Acute or chronic infections of the lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Central Study Contacts

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

CONTACT

+49 170 3750718alexander.franz@ukbonn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., B.Sc.

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

October 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)