Condition category
Musculoskeletal Diseases
Date applied
23/07/2019
Date assigned
29/07/2019
Last edited
29/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Treatment for fractures of long bones in the leg (femur and tibia) usually involves the insertion fo a metal rod into the bone cavity to provide additional strength and support (intermedullary nailing). In one to two percent of cases the bone cavity can become infected. Treating the infected area involves removal of the metal rod and drilling out (reaming) the infected bone. The aim of this study is to compare the postoperative effects of two methods of intermedullary reaming.

Who can participate?
Patients aged over 18 years diagnosed with an infection of the bone cavity previously treated by insertion of a metal rod into the bone.

What does the study involve?
Patients undergo surgical removal of the infected metal rod followed by either conventional reaming or reaming using the Reamer / Irrigator / Aspirator (RIA) system (Synthes, Inc. West Chester, Philadelphia, PA, USA). Patients then attended routine follow up visits to the hospital at 1, 3, 6, 12 and 24 months after the operation.

What are the possible benefits and risks of participating?
During the research, there is no direct benefit to the participant

Where is the study run from?
Federal University of São Paulo - Hospital São Paulo (UNIFESP)

When is the study starting and how long is it expected to run for?
August 2013 to July 2015

Who is funding the study?
Universidade Federal de São Paulo

Who is the main contact?
Mauro Salles
mauro.salles@unifesp.br

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mauro Salles

ORCID ID

http://orcid.org/0000-0002-5443-6024

Contact details

Rua Visconde de Ouro Preto 77
apto193
São Paulo
01303-060
Brazil
+5511985360055
mauro.salles@unifesp.br

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

354.934

Study information

Scientific title

The intramedullary reaming modality for the management of postoperative long bone infection: a prospective randomized controlled trial

Acronym

Study hypothesis

To compare the efficacy of reamer/irrigator/aspirator (RIA) with conventional reaming followed by insertion of antibiotic-loaded cement, for the treatment of intramedullary nail infection of long bones

Ethics approval

Approved 16/08/2013, Research and Ethics Committee of the Federal University of São Paulo (UNIFESP) (Rua Botucatu, 572 1º Andar Conj. 14, Vila Clementino, Sao Paulo, Brazil; +55 115539-7162; cepunifesp@unifesp.br), ref: 354.934

Study design

Prospective randomized controlled single-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intramedullary nail infection

Intervention

A noninferiority, randomized clinical trial was carried out involving patients of whom a locked IMN implant of the femur and/or tibia was retrieved and who all met the clinical and radiological criteria for IMN-associated osteomyelitis. Patients were randomized into two groups: RIA alone versus conventional reaming followed by antibiotic-loaded cement insertion. Both groups also underwent six-weeks of antibiotic treatment according to the results of the antibiogram. Patients were evaluated after 1, 3, 6, 12 and 24 months for radiological and clinical follow-up.

Consecutive patients with clinically suspected intramedullary infection who underwent nailing explantation and surgical debridement were randomised to receive either conventional reaming or reamer/irrigator/aspirator (RIA) of the presumed infected medullary canal.

Patients presenting intramedullary infection were assessed at the trauma unit and the outpatient setting by the infectious disease specialist and recruited after signed consent. Allocation of patients to the treatment groups took place at the time of anesthesia within the operative room. Then, randomization to conventional reaming or RIA was set up in a simple randomization procedure (1:1 ratio) with sealed opaque envelopes, sequentially numbered. The CONSORT guidelines were followed throughout the study.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Intramedullary infection two-year remission rate, performed using all randomized patients that completed at least one-year of follow-up in the per-protocol (PP) analysis. Patients were considered in remission when there was an absence of clinical, laboratory and radiological signs of infection, assessed in the last medical consultation (at least 12 months follow-up). Cases that did not require re-operation or further antibiotic administration for the same site of infection were also considered to be in remission.

Secondary outcome measures

Preoperative and postoperative pain measured by the Visual Analog Scale (EVA) scale at baseline and 1, 3, 6, 12 and 24 months postoperatively

Overall trial start date

24/06/2013

Overall trial end date

30/03/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 years and over
2. Previous tibia or femur intramedullary locking nail fixation who met the definitive clinical and radiological diagnosis of osseous infection

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Participant exclusion criteria

1. Diaphyseal diameter < 10 mm
2. Previous infection of the affected bone and patients with HIV or chronic renal failure were excluded from the study

Recruitment start date

30/08/2013

Recruitment end date

20/07/2015

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of São Paulo - Hospital São Paulo (UNIFESP)
Rua Napoleão de Barros 715 Vila Clementino
São Paulo
04024-002
Brazil

Sponsor information

Organisation

Federal University Of São Paulo (UNIFESP)

Sponsor details

Rua Napoleão de Barros 715
Vila Clementino
São Paulo
04024-002
Brazil
+551155764848 VOIP 3006
mauro.salles@unifesp.br

Sponsor type

University/education

Website

www.unifesp.br

Funders

Funder type

University/education

Funder name

Universidade Federal de São Paulo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in Patient Safety in Surgery Journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Carlos Augusto Finelli (email: c.finelli@cecot.com.br). The type of data is a complete Excel datasheet. The data is already available upon request and will become available for a long as necessary. Data will be shared upon reasonable request. The criteria access would be a simple email contact with the corresponding author, explaining the reasons for accessing the data. Additional analysis may also be requested upon reasonable rational. No further participants consent will be required including additional comments on data anonymization, as it has already been gathered and declared.

Intention to publish date

24/07/2019

Participant level data

Available on request

Basic results (scientific)

After 24 months, the rate of infection remission was similar between the two groups, 87% in the RIA group and 95.5% in the conventional reaming group (p=0.60). Among four patients who had recurrence of infection, the time to reappearance of symptoms varied from 20 days to twenty-two months. Staphylococcus aureus and coagulase-negative Staphylococci were isolated in 23 (40.4%) and 13 (22.9%) patients, respectively. Interestingly, we identified 20% (9/45) of polymicrobial infection.

Publication list

Publication citations

Additional files

Editorial Notes

29/07/2019: Trial’s existence confirmed by the Federal University of São Paulo