LOQTEQ® Antibacterial Pre-Market Study
Fractures, Open, Fractures, Closed, Surgical Site Infection
About this trial
This is an interventional treatment trial for Fractures, Open focused on measuring Silver-coating, antibacterial, Fibula, Orthopaedic
Eligibility Criteria
Inclusion Criteria:
- Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
- Subject aged 18 years and over.
- Subjects with fractures of the distal tibia (AO type 43 injuries).
Exclusion Criteria:
- Subject unable to give written informed consent, is unlikely to cooperate or is legally incompetent.
- Subjects with consumptive / malignant primary disease and a life expectancy of less than 12 months.
- Subjects with a known allergy to silver or any components of the device.
- Subjects with an already implanted silver-coated device other than the investigational device.
- History of or ongoing soft-tissue and/or bone and/or implant infection signs at the distal tibia and/or distal fibula.
Subjects with a possible contraindication for the investigational and comparator devices
- infection or inflammation requiring treatment with antibiotics or with positive cultures;
- acute and chronic osteomyelitis at or close to the surgical field;
- high anesthesia risk subjects (ASA Physical Status Classification of 4 to 6);
- severe soft tissue swelling impacting normal wound healing;
- insufficient soft tissue coverage;
- subjects with neurological disorders who cannot follow instructions given by their physician;
- subjects with past history of severe medical disorders of extremity which may impact study device efficacy and safety according to investigator's judgment;
- severe chronic or acute comorbidity according to investigator's judgement (such as arthritis or neurogenic disorders).
- Female subjects who are pregnant or lactating at Screening Visit.
- Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions according to investigator's judgement can be included.
- Males with partners who are pregnant or lactating or of child bearing potential, and are unwilling to use condoms for the duration of the study.
- Participation in any other study involving an investigational drug or device currently or within the past 3 months.
- Subject has a significant history of drug/solvent abuse or a positive drugs of abuse test at Screening Visit.
- Subject has a history of alcohol abuse or currently drinks more than 224 g alcohol for men and 112 g alcohol for women per week or has a positive alcohol test (≥0,5 per mil) at Screening Visit. Subjects who drop out due to this criterion may be re-enrolled at a later point in time, provided all other entry criteria are still fulfilled and the implant surgery has not been performed yet.
- Subject is scheduled for an MRI examination after implantation of the study device.
- Subjects with stage IV vascular disease, i.e. with presence of necrotic tissue at the distal tibia.
Sites / Locations
- Universitätsklinikum RegensburgRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Silver-coated Implant
Uncoated Implant
The summary description and intended purpose of the investigational device (LOQTEQ® antibacterial silver-coated system) is the same as that of the comparator device (LOQTEQ® 3.5 System (uncoated) system). The investigational device differs from the comparator device in that its surface which has been modified by the addition of an antibacterial coating.
The summary description and intended purpose of the investigational device (LOQTEQ® antibacterial silver-coated system) is the same as that of the comparator device (LOQTEQ® 3.5 System (uncoated) system) and differes only in the lack of the antibacterial coating.