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

NCT01282294 | Completed Results

• 1 other identifier: STU-BIO-T-XX-190-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Tibia Fractures

Outcome Measures

Primary Outcomes (6)

• Quality of Life: SF-12 Physical Component Summary (PCS)

  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.

  3, 6, 12 and 18 months post-operatively

• Quality of Life: SF-12 Mental Component Summary (MCS)

  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.

  3, 6, 12 and 18 months post-operatively

• Quality of Life: EQ-5D

  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.

  3, 6, 12 and 18 months post-operatively

• Functional Outcome: IOWA Ankle Score

  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.

  Baseline, 3, 6, 12 and 18 months post-operatively

• Functional Outcome: WOMAC

  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.

  3, 6, 12 and 18 months post-operatively

• Infection Adverse Events

  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

  0 - 18 months

Secondary Outcomes (9)

• Evidence of Anatomic Bone Union According to Johnson Classification

  12 months

• Evidence of Economic Bone Union According to Johnson Classification

  12 months

• Evidence of Functional Bone Union According to Johnson Classification

  12 months

• Surgeon's Perceived Satisfaction

  6 weeks, 3 and 6 months post-operatively

• Likelihood to Develop Wound Infection Assessed by Surgeon

  6 weeks, 3 and 6 months post-operatively

Study Arms (1)

ETN PROtect

There is only 1 cohort in this case series

Device: ETN PROtect

Interventions

ETN PROtect DEVICE

Expert Tibial Nail PROtect with Gentamicin coating

ETN PROtect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ER with a tibia fracture

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synthes GmbH: lead

Study Sites (4)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital of Münster

Münster, 48149, Germany

Location

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Synthes GmbH

clinicalaffairs.emea@synthes.com

0041 32 720 44 65

Study Officials

• Michael J. Raschke, MD

  University Hospital of Münster, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 17, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-02

Locations

DE (4)