NCT01691599

Brief 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. 1.What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
  2. 2.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?
  3. 3.How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
  4. 4.What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
  5. 5.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?
  6. 6.Hospital standard hygienic and antibiotic protocol for infection prevention
  7. 7.Subject demographics
  8. 8.Time between injury and surgery and between admission and surgery
  9. 9.Fracture type (AO Müller classification)
  10. 10.Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
  11. 11.Fracture management and implant type
  12. 12.Surgical details such as duration of surgery
  13. 13.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?
  14. 14.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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

11 active sites

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

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 22, 2021

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

September 17, 2012

Last Update Submit

July 21, 2021

Conditions

Tibia Fracture

Keywords

InfectionOpen tibia fracturesClosed tibia fracturesWound infection

Outcome Measures

Primary Outcomes (1)

  • 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)

    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)

    Baseline and up to 5 day postoperative and 3months and 6months and 12 months

Study Arms (1)

Tibia fractures

Patients with open and closed tibia fracture treated with internal fixation in India

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with open or closed tibia fractures

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hi Tech Hospital

Gandhinagar, Gujarat, 382006, India

Location

Dr. B.R. Ambedkar Medical College Hospital

Bangalore, Karnataka, 560 045, India

Location

MOSC Medical College

Kochi, Kerala, 625 007, India

Location

Kolhapur Institute of Orthopedics and Trauma

Kolhāpur, Maharashtra, 416 001, India

Location

Dr. Balabhai Nanavati Hospital

Mumbai, Maharashtra, 400 056, India

Location

Dr. R. N. Cooper Hospital

Mumbai, Maharashtra, 400 056, India

Location

Jai Hospital Pvt. Ltd.

Nashik, Maharashtra, 422 002, India

Location

Sancheti Hospital

Pune, Maharashtra, 411005, India

Location

Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan

Sangli, Maharashtra, 416 416, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160 012, India

Location

Mukhopadhaya Orthopaedic Clinic and Research Centre

Bihār, 800 004, India

Location

Related Publications (1)

  • 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.

    PMID: 28410572DERIVED

MeSH Terms

Conditions

Tibial FracturesInfectionsWound Infection

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Prakash J Doshi, MD

    Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 22, 2021

Record last verified: 2015-06

Locations

IN(11)