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: February 25, 2015
Last verified: February 2015
  Purpose

This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (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 Physical Component Summary (PCS) [ Time Frame: 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]

    The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.

    It was administered at 3, 6, 12 and 18 months post-operatively.


  • Quality of Life: SF-12 Mental Component Summary (MCS) [ Time Frame: 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]

    The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.

    It was administered at 3, 6, 12 and 18 months post-operatively.


  • Quality of Life: EQ-5D [ Time Frame: 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]
    The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.

  • Functional Outcome: IOWA Ankle Score [ Time Frame: Baseline, 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]
    The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.

  • Functional Outcome: WOMAC [ Time Frame: 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.

    Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations.


  • Infection Adverse Events [ Time Frame: 0 - 18 months ] [ Designated as safety issue: Yes ]

    Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:

    • superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue
    • deep incisional SSI, affecting deep soft tissue
    • organ/ space SSI (Osteomyelitis), affecting joint or bursa


Secondary Outcome Measures:
  • Evidence of Anatomic Bone Union According to Johnson Classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Anatomic bone union was assessed according to Johnson et al.*:

    A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.

    *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57


  • Evidence of Economic Bone Union According to Johnson Classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Economic bone union was assessed according to Johnson et al.*:

    E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.

    *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57


  • Evidence of Functional Bone Union According to Johnson Classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Functional bone union was assessed according to Johnson et al.*:

    F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.

    *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57


  • Surgeon's Perceived Satisfaction [ Time Frame: 6 weeks, 3 and 6 months post-operatively ] [ Designated as safety issue: No ]
    Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).

  • Likelihood to Develop Wound Infection Assessed by Surgeon [ Time Frame: 6 weeks, 3 and 6 months post-operatively ] [ Designated as safety issue: No ]
    The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).

  • Likelihood to Develop a Non-union Assessed by Surgeon [ Time Frame: 6 weeks, 3 and 6 months post-operatively ] [ Designated as safety issue: No ]
    The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).

  • Pain by Visual Analog Scale (VAS) [ Time Frame: 6 weeks, 3, 6, 12 and 18 months post-operatively ] [ Designated as safety issue: No ]
    Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.

  • Patient's Perceived Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.

  • Time to Full Weight Bearing [ Time Frame: 0 - 18 months ] [ Designated as safety issue: No ]
    The time from surgery to full weight bearing was assessed in days.


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
Results First Received: January 27, 2015
Last Updated: February 25, 2015
Health Authority: Germany: BfArM

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

ClinicalTrials.gov processed this record on May 27, 2015