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

Sponsor
University Hospital, Bonn
Study ID
NCT06947655
Status
Recruiting

Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VBM Tourniquet — DEVICE
    Perioperative VBM-Tourniquet Application with a fixation pressure of 15mmHg.
  • Adaptive Cuff — DEVICE
    Perioperative Delfi-Tourniquet Application with a fixation pressure of 15mmHg.

Study Details

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.

Key Dates

First listed
Apr 27, 2025
Start date
Oct 1, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Blood Loss [ Time Frame: Perioperative ]

Central Contacts

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