Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH
ClinicalTrials.gov Identifier:
NCT01282294
First received: January 21, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This post market clinical follow-up is to confirm the clinical usefulness of the ETN PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.


Condition Intervention
Tibia Fractures
Device: ETN PROtect

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails

Resource links provided by NLM:


Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • Quality of Life (SF-12, EQ-5D) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Functional Outcome (IOWA, WOMAC, Range of motion) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Adverse Events or Complications [ Time Frame: 0 - 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone Union [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Surgeon's perceived effectiveness and patient's satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pain by Visual Analog Scale (VAS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to weight bearing [ Time Frame: 0 - 18 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ETN PROtect
There is only 1 cohort in this case series
Device: ETN PROtect
Expert Tibial Nail PROtect with Gentamicin coating

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the ER with a tibia fracture

Criteria

Inclusion Criteria:

  • Adult patients aged 18 years or more
  • Open or closed tibia fracture according to the surgical technique

Exclusion Criteria:

  • Women who are pregnant or breast-feeding or are planning to become pregnant during the study
  • Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
  • Patients with a known allergy to aminoglycosides
  • Physical or mental incapacity, which makes it impossible to obtain informed consent
  • History of drug and alcohol abuse
  • Patient unlikely to cooperate
  • Legal incompetence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282294

Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
University Hospital of Münster
Münster, Germany, 48149
Sponsors and Collaborators
Synthes GmbH
Investigators
Principal Investigator: Michael J. Raschke, MD University Hospital of Münster, Germany
  More Information

No publications provided

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT01282294     History of Changes
Other Study ID Numbers: STU-BIO-T-XX-190-02
Study First Received: January 21, 2011
Last Updated: January 30, 2014
Health Authority: Germany: BfArM

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014