LOQTEQ® Antibacterial Pre-Market Study
Study Details
Study Description
Brief Summary
aap001 is a randomized, controlled, subject and observer-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Antimicrobial coatings of implants are of interest to reduce infection rate in orthopaedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evaluate the clinical performance of a silver-coating for locking plates for fracture treatment.
The study design has to respect different criteria, such as feasibility, focus on overall complications, such as functional impairment, fracture healing and particularly on infection rates. Distal tibia fractures were chosen due to the high prevalence of infections in this type of injuries, which warrants a particular benefit of antimicrobial prophylaxis and thus might allow to see a statistical trend in favor of the coated product. The study design was defined as randomized, controlled, subject and observer-blinded, multi-center study in subjects with fractures of the distal tibia with a total of 226 patients. A number of 113 patients are planned for each of the two treatment arms with treatment of the fracture with a silver-coated device (first arm) or with an uncoated device (second arm). Inclusion criteria are closed and open fractures of the distal tibia with Gustilo-Anderson type I to Gustilo-Anderson type IIIB type older than 18 years. Primary outcome parameter is the Anticipated Adverse Device Effects (AADE) including all typical complications of this type of injury, such as functional impairment of the affected limb, non-union and infections based on a non-inferiority study design. Also, silver-typical complications, such as argyria, are included. Secondary parameters are infection rates and fracture healing. Follow-up of patients includes five visits with clinical and X-ray evaluations with a follow-up time of 12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Silver-coated 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. |
Device: Implantation
Fractures of the distal tibia (AO43) are treated with a trauma implant.
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| Active Comparator: 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) and differes only in the lack of the antibacterial coating. |
Device: Implantation
Fractures of the distal tibia (AO43) are treated with a trauma implant.
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Outcome Measures
Primary Outcome Measures
- Anticipated Adverse Device Effect (AADE) [Implantation until 12 months follow-up]
The primary endpoint for this study is the proportion of subjects with at least one Anticipated Adverse Device Effect (AADE) within 12 months of implantation.
Secondary Outcome Measures
- Proportion of subjects with device related infections [Implantation until 12 months follow-up]
Investigate the proportion of subjects with device-related infections occurring after successful implantation of study device and end of the 12-month FU and compare the rate between treatment arms.
- Radiographic (X-ray) fracture healing [Implantation until 12 months follow-up]
Investigate fracture healing assessed by local and central reviewer and compare the rate of completely healed subjects between treatment arms.
- Hospitalization and nights spent in hospital [Implantation until 12 months follow-up]
Investigate the number of hospitalizations occurring in the first 12 months post-implantation and the nights spent in hospital and compare the numbers between treatment arms.
- Change in Ankle-Hindfoot Score (AOFAS) [Implantation until 12 months follow-up]
Investigate the change in AOFAS at each FU visit and compare endpoint between the treatment arms. The change is defined as the difference between AOFAS at the respective FU and the AOFAS at Screening/Enrollment Visit.
- Change in Average Pain at Rest (VAS) [Implantation until 12 months follow-up]
Investigate the change in average pain at rest at each FU visit and compare endpoint between the treatment arms. The Change in Average Pain is defined as the difference between VAS value at the respective FU and at Screening/Enrollment Visit.
- Change in Disability Rating Index (DRI) [Implantation until 12 months follow-up]
Investigate the change in the disability rating index at each FU visit and compare endpoint between the treatment arms. The change in DRI is defined as the difference between DRI at the respective FU and at Screening/Enrollment Visit.
- EQ-5D-5L [Implantation until 12 months follow-up]
Investigate all items assessed in the EQ-5D-5L questionnaire. The changes from Screening will be compared between treatment arms for all FU visits.
- Weight bearing [Implantation until 12 months follow-up]
Investigate the proportion of subjects with full weight bearing at each FU visit and compare this endpoint between the treatment arms.
- Change in Silver Serum Levels [Implantation until 12 months follow-up]
Investigate the change in silver serum levels at each scheduled FU visit and compare endpoint between the treatment arms. The change in silver serum level is defined as the difference between the respective silver level at the respective FU and the silver level at Screening/Enrollment Visit.
- Proportion of subjects with Treatment emergent adverse events (TEAE) [Implantation until 12 months follow-up]
Investigate the proportion of subjects with TEAEs during the 12-month FU and compare the rate between treatment arms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
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Subject aged 18 years and over.
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Subjects with fractures of the distal tibia (AO type 43 injuries).
Exclusion Criteria:
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Subject unable to give written informed consent, is unlikely to cooperate or is legally incompetent.
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Subjects with consumptive / malignant primary disease and a life expectancy of less than 12 months.
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Subjects with a known allergy to silver or any components of the device.
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Subjects with an already implanted silver-coated device other than the investigational device.
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History of or ongoing soft-tissue and/or bone and/or implant infection signs at the distal tibia and/or distal fibula.
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Subjects with a possible contraindication for the investigational and comparator devices
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infection or inflammation requiring treatment with antibiotics or with positive cultures;
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acute and chronic osteomyelitis at or close to the surgical field;
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high anesthesia risk subjects (ASA Physical Status Classification of 4 to 6);
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severe soft tissue swelling impacting normal wound healing;
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insufficient soft tissue coverage;
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subjects with neurological disorders who cannot follow instructions given by their physician;
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subjects with past history of severe medical disorders of extremity which may impact study device efficacy and safety according to investigator's judgment;
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severe chronic or acute comorbidity according to investigator's judgement (such as arthritis or neurogenic disorders).
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Female subjects who are pregnant or lactating at Screening Visit.
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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.
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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.
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Participation in any other study involving an investigational drug or device currently or within the past 3 months.
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Subject has a significant history of drug/solvent abuse or a positive drugs of abuse test at Screening Visit.
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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.
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Subject is scheduled for an MRI examination after implantation of the study device.
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Subjects with stage IV vascular disease, i.e. with presence of necrotic tissue at the distal tibia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Regensburg | Regensburg | Bayern | Germany | 93042 |
Sponsors and Collaborators
- aap Implantate AG
- German Federal Ministry of Education and Research
Investigators
- Principal Investigator: Volker Alt, Prof. Dr., Universitätsklinikum Regensburg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- aap001