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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tibia Fractures

Intervention / Treatment
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* Device: ETN PROtect


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ETN PROtect<br>There is only 1 cohort in this case series | Device: ETN PROtect<br>* Expert Tibial Nail PROtect with Gentamicin coating<br>|

What is the study measuring?
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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 |