NCT06919770

Brief Summary

A taurolidine-based antimicrobial solution, was evaluated for its safety and efficacy in preventing infections associated with prosthetic materials, such as joint replacements, plates, nails, and screws. This prospective observational study compared Taurolidine to infection rates from scientific literature.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
57mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress48%
Jan 2022Dec 2030

Study Start

First participant enrolled

January 1, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

8.6 years

First QC Date

April 2, 2025

Last Update Submit

January 15, 2026

Conditions

Infection PreventionOsteosynthesis

Outcome Measures

Primary Outcomes (1)

  • Infection

    infection of osteosynthesis materials within 3 months after index procedure

    3 months

Secondary Outcomes (1)

  • AE all grades, infections and all cause mortality during total follow up

    36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

trimalleolar farcture lower extremity, requiring osteosynthesis and external fixation undergoing revision to internal fixation; osteosynthesis of upper extremity undergoing revision to receive inverse shoulder prosthesis

You may qualify if:

  • requires osteosynthesis with placement of prosthetic materials

You may not qualify if:

  • minor, can't or won't sign PIC, can't undergo surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Cuxhaven

Cuxhaven, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
coordinating Principal investigator

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 9, 2025

Study Start

January 1, 2022

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)