NCT03602209

Brief Summary

The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1. The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

January 17, 2017

Last Update Submit

July 30, 2018

Conditions

Implant Infection

Keywords

implant-related infectionsorthopaedicsimplant removalantibiotic durationoutcome

Outcome Measures

Primary Outcomes (2)

  • Remission of infection

    Clinical evaluation

    12 months

  • Adverse events

    Clinical adverse events

    12 months

Study Arms (2)

4 weeks of treatment

EXPERIMENTAL
Procedure: Removal of infected implantDrug: Antibiotic durations

6 weeks of treatment

ACTIVE COMPARATOR
Procedure: Removal of infected implantDrug: Antibiotic durations

Interventions

Removal of infected implantPROCEDURE
4 weeks of treatment6 weeks of treatment
Antibiotic durationsDRUG
4 weeks of treatment6 weeks of treatment

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥17 years old)
  • Total removal of the implant

You may not qualify if:

  • Primary native joint septic arthritis;
  • Co-trimoxazole prophylaxis because of immunosuppression;
  • Left-side endocarditis;
  • Persistent implant material in the infected area.
  • Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Al-Mayahi M, Betz M, Muller DA, Stern R, Tahintzi P, Bernard L, Hoffmeyer P, Suva D, Uckay I. Remission rate of implant-related infections following revision surgery after fractures. Int Orthop. 2013 Nov;37(11):2253-8. doi: 10.1007/s00264-013-2092-1. Epub 2013 Sep 20.

    PMID: 24052163BACKGROUND

Study Officials

  • Ilker Uçkay, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending, Docent Dr. med. Ilker Uçkay

Study Record Dates

First Submitted

January 17, 2017

First Posted

July 26, 2018

Study Start

March 1, 2015

Primary Completion

February 28, 2018

Study Completion

May 18, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)