Comparision of bone-drilling techniques in the management of long bone infection following fracture repair by metal rod insertion
| ISRCTN | ISRCTN82233198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82233198 |
| Secondary identifying numbers | 354.934 |
- Submission date
- 23/07/2019
- Registration date
- 29/07/2019
- Last edited
- 10/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Rua Visconde de Ouro Preto 77, apto193
São Paulo
01303-060
Brazil
 ORCID ID |
0000-0002-5443-6024 |
|---|---|
| Phone | +5511985360055 |
| mauro.salles@unifesp.br |
Study information
| Study design | Prospective randomized controlled single-blinded clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The intramedullary reaming modality for the management of postoperative long bone infection: a prospective randomized controlled trial |
| 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(s) | 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 |
| 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 |
| 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 study start date | 24/06/2013 |
| Overall study end date | 30/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 44 |
| 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 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
Study participating centre
Vila Clementino
São Paulo
04024-002
Brazil
Sponsor information
University/education
Rua Napoleão de Barros 715
Vila Clementino
São Paulo
04024-002
Brazil
| Phone | +551155764848 VOIP 3006 |
|---|---|
| mauro.salles@unifesp.br | |
| Website | www.unifesp.br |
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 24/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in Patient Safety in Surgery Journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/12/2019 | 10/01/2020 | Yes | No |
Editorial Notes
10/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
27/08/2019: Internal review.
29/07/2019: Trial’s existence confirmed by the Federal University of São Paulo
