Tibia FractureNCT01691599
Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India
An observational study of Tibia Fracture, run by AO Clinical Investigation and Publishing Documentation at 11 sites in India.
Trial summary
The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Tibia Fracture
- How many people
- 800 participants
- Where
- 11 sitesIndia
- Study dates
- Aug 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with open or closed tibia fractures
Who may be able to join
- Men and women who are 18 years of age or older.
- Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.
- Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
- Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.
Who cannot join
- Previous wound infection or osteomyelitis at the same limb (according to subject history).
- Subjects who plan to undergo conversion surgery at a different hospital.
- Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
- Immunological deficiency disease.
- Tumor related fractures.
- Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
Show all 9Show fewer
- Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
- Subject is a prisoner.
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Dr. B.R. Ambedkar Medical College Hospital
Bangalore, Karnataka, 560 045
Mukhopadhaya Orthopaedic Clinic and Research Centre
Bihār, 800 004
Post Graduate Institute of Medical Education and Research
Chandigarh, Punjab, 160 012
Hi Tech Hospital
Gandhinagar, Gujarat, 382006
MOSC Medical College
Kochi, Kerala, 625 007
Kolhapur Institute of Orthopedics and Trauma
Kolhāpur, Maharashtra, 416 001
Dr. Balabhai Nanavati Hospital
Mumbai, Maharashtra, 400 056
Dr. R. N. Cooper Hospital
Mumbai, Maharashtra, 400 056
Jai Hospital Pvt. Ltd.
Nashik, Maharashtra, 422 002
Sancheti Hospital
Pune, Maharashtra, 411005
Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan
Sangli, Maharashtra, 416 416
About this study
Official title: Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.
The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions:
- What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
- What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation?
Read more
Secondary objectives
- How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
- What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
- What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation?
- Hospital standard hygienic and antibiotic protocol for infection prevention
- Subject demographics
- Time between injury and surgery and between admission and surgery
- Fracture type (AO Müller classification)
- Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
- Fracture management and implant type
- Surgical details such as duration of surgery
- Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections?
- Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?
- Conditions
- Tibia Fracture
- Keywords
- Infection, Open tibia fractures, Closed tibia fractures, Wound infection
- Medical subject headings
- Tibial Fractures, Infections, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tibia fractures | Patients with open and closed tibia fracture treated with internal fixation in India |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of infection
LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
Measured: From surgery until the date of first documented infection assessed up to 1 year
Secondary outcomes (1)
Change in Quality of life measurement (EQ-5D)
Measured: Baseline and up to 5 day postoperative and 3months and 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prakash J Doshi, MD, Principal investigator, Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691599
- Sponsor's protocol ID
- INFINITI
- Status last verified
- Jun 2015
- First submitted
- 17 Sep 2012
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Doshi P, Gopalan H, Sprague S, Pradhan C, Kulkarni S, Bhandari M. Incidence of infection following internal fixation of open and closed tibia fractures in India (INFINITI): a multi-centre observational cohort study. BMC Musculoskelet Disord. 2017 Apr 14;18(1):156. doi: 10.1186/s12891-017-1506-4.
PubMed 28410572
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.
- ClinicalTrials.gov ID
- NCT01691599
- Acronym / sponsor ID
- INFINITI
- Conditions
- Tibia Fracture
- Keywords
- Infection, Open tibia fractures, Closed tibia fractures, Wound infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions:
- What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
- What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation?
Secondary objectives
- How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
- What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
- What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation?
- Hospital standard hygienic and antibiotic protocol for infection prevention
- Subject demographics
- Time between injury and surgery and between admission and surgery
- Fracture type (AO Müller classification)
- Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
- Fracture management and implant type
- Surgical details such as duration of surgery
- Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections?
- Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tibia fractures | – | –Patients with open and closed tibia fracture treated with internal fixation in India |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with open or closed tibia fractures
Key inclusion criteria (4 listed)
- Men and women who are 18 years of age or older.
- Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.
- Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
- Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.
Key exclusion criteria (9 listed)
- Previous wound infection or osteomyelitis at the same limb (according to subject history).
- Subjects who plan to undergo conversion surgery at a different hospital.
- Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
- Immunological deficiency disease.
- Tumor related fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of infection
Time frame: From surgery until the date of first documented infection assessed up to 1 year
LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
1 secondary outcome
Change in Quality of life measurement (EQ-5D)
Time frame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 28410572Doshi P, Gopalan H, Sprague S, Pradhan C, Kulkarni S, Bhandari M. Incidence of infection following internal fixation of open and closed tibia fractures in India (INFINITI): a multi-centre observational cohort study. BMC Musculoskelet Disord. 2017 Apr 14;18(1):156. doi: 10.1186/s12891-017-1506-4.
Related trials for Tibia Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prakash J Doshi, MD principal investigator
Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibia Fracture, run by AO Clinical Investigation and Publishing Documentation at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of infection (time frame: From surgery until the date of first documented infection assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.