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

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

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.

Study Overview

• Status: Completed
• Conditions: Tibia Fractures
• Intervention / Treatment: Device: ETN PROtect

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite - Universitatsmedizin Berlin
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Heidelberg, Germany, 69120
    • Universitatsklinikum Heidelberg
  • Münster, Germany, 48149
    • University Hospital of Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ER with a tibia fracture

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ETN PROtect; There is only 1 cohort in this case series	Device: ETN PROtect; Expert Tibial Nail PROtect with Gentamicin coating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Anatomic Bone Union According to Johnson Classification	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	12 months
Evidence of Economic Bone Union According to Johnson Classification	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	12 months
Evidence of Functional Bone Union According to Johnson Classification	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	12 months
Surgeon's Perceived Satisfaction	Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).	6 weeks, 3 and 6 months post-operatively
Likelihood to Develop Wound Infection Assessed by Surgeon	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).	6 weeks, 3 and 6 months post-operatively
Likelihood to Develop a Non-union Assessed by Surgeon	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).	6 weeks, 3 and 6 months post-operatively
Pain by Visual Analog Scale (VAS)	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.	6 weeks, 3, 6, 12 and 18 months post-operatively
Patient's Perceived Satisfaction	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.	6 months
Time to Full Weight Bearing	The time from surgery to full weight bearing was assessed in days.	0 - 18 months

Collaborators and Investigators

• Sponsor: Synthes GmbH
• Investigators: Principal Investigator: Michael J. Raschke, MD, University Hospital of Münster, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: STU-BIO-T-XX-190-02