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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014