N/A
N=100
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
Tibia Fractures
Bottom Line
View on ClinicalTrials.gov: NCT01282294 ↗Enrolled (actual)
100
Serious AEs
38.4%
Results posted
Feb 2015
Primary outcome: Primary: Quality of Life: SF-12 Physical Component Summary (PCS) — 36.9; 41.2; 45.6; 44.6 scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ETN PROtect (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synthes GmbH
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life: SF-12 Physical Component Summary (PCS) |
36.9; 41.2; 45.6; 44.6 | — |
| PRIMARY Quality of Life: SF-12 Mental Component Summary (MCS) |
52.7; 53.2; 53.3; 53.1 | — |
| PRIMARY Quality of Life: EQ-5D |
0.7; 0.8; 0.8; 0.9 | — |
| PRIMARY Functional Outcome: IOWA Ankle Score |
86.3; 62.9; 76.4; 81.2; 85.2 | — |
| PRIMARY Functional Outcome: WOMAC |
29.3; 24.6; 19.2; 18.2 | — |
| PRIMARY Infection Adverse Events |
6; 5; 0 | — |
| SECONDARY Evidence of Anatomic Bone Union According to Johnson Classification |
4; 2; 9; 11; 52 | — |
| SECONDARY Evidence of Economic Bone Union According to Johnson Classification |
3; 19; 8; 8; 40 | — |
| SECONDARY Evidence of Functional Bone Union According to Johnson Classification |
4; 1; 24; 17; 32 | — |
| SECONDARY Surgeon's Perceived Satisfaction |
18.2; 18.9; 14.9 | — |
| SECONDARY Likelihood to Develop Wound Infection Assessed by Surgeon |
19.6; 14.6; 14.4 | — |
| SECONDARY Likelihood to Develop a Non-union Assessed by Surgeon |
26.4; 23.0; 19.6 | — |
| SECONDARY Pain by Visual Analog Scale (VAS) |
19.3; 24.3; 27.0; 21.0; 23.0 | — |
| SECONDARY Patient's Perceived Satisfaction |
63.8 | — |
| SECONDARY Time to Full Weight Bearing |
90.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01282294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.