Back to resultsLOQTEQ® Antibacterial Pre-Market Study
Primary Purpose
Fractures, Open, Fractures, Closed, Surgical Site Infection
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantation
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
Silver-coated Implant
Uncoated Implant
Arm Description
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.
Outcomes
Primary Outcome Measures
Anticipated Adverse Device Effect (AADE)
The primary endpoint for this study is the proportion of subjects with at least one predefined Anticipated Adverse Device Effect (AADE) within 12 months of implantation.
Secondary Outcome Measures
Proportion of subjects with device related infections
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
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
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)
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 the 1-week FU.
Change in Average Pain at Rest (VAS)
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 the AOFAS at the 1-week FU.
Change in Disability Rating Index (DRI)
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 the 1-week FU.
EQ-5D-5L
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
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
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)
Investigate the proportion of subjects with TEAEs during the 12-month FU and compare the rate between treatment arms.
Full Information
NCT ID
NCT05260463
First Posted
January 11, 2022
Last Updated
August 4, 2023
Sponsor
aap Implantate AG
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT05260463
Brief Title
LOQTEQ® Antibacterial Pre-Market Study
Official Title
LOQTEQ® Antibacterial Pre-Market Study Randomized, Controlled, Subject-blinded, Multi-center Study of LOQTEQ® Antibacterial Locking Plates in Subjects With Fractures of the Distal Fibula (AO Type 4F3 Injuries)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
aap Implantate AG
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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 infection rates. The study design was defined as randomized, controlled, subject-blinded, multi-center study in subjects with fractures of the distal fibula with a total of 254 patients. A number of 127 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 fibula 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Open, Fractures, Closed, Surgical Site Infection, Fracture of Fibula
Keywords
Silver-coating, antibacterial, Fibula, Orthopaedic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silver-coated Implant
Arm Type
Experimental
Arm Description
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.
Arm Title
Uncoated Implant
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implantation
Intervention Description
Fractures of the distal fibula are treated with a trauma implant.
Primary Outcome Measure Information:
Title
Anticipated Adverse Device Effect (AADE)
Description
The primary endpoint for this study is the proportion of subjects with at least one predefined Anticipated Adverse Device Effect (AADE) within 12 months of implantation.
Time Frame
Implantation until 12 months follow-up
Secondary Outcome Measure Information:
Title
Proportion of subjects with device related infections
Description
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.
Time Frame
Implantation until 12 months follow-up
Title
Radiographic (X-ray) fracture healing
Description
Investigate fracture healing assessed by local and central reviewer and compare the rate of completely healed subjects between treatment arms.
Time Frame
Implantation until 12 months follow-up
Title
Hospitalization and nights spent in hospital
Description
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.
Time Frame
Implantation until 12 months follow-up
Title
Change in Ankle-Hindfoot Score (AOFAS)
Description
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 the 1-week FU.
Time Frame
Implantation until 12 months follow-up
Title
Change in Average Pain at Rest (VAS)
Description
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 the AOFAS at the 1-week FU.
Time Frame
Implantation until 12 months follow-up
Title
Change in Disability Rating Index (DRI)
Description
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 the 1-week FU.
Time Frame
Implantation until 12 months follow-up
Title
EQ-5D-5L
Description
Investigate all items assessed in the EQ-5D-5L questionnaire. The changes from Screening will be compared between treatment arms for all FU visits.
Time Frame
Implantation until 12 months follow-up
Title
Weight bearing
Description
Investigate the proportion of subjects with full weight bearing at each FU visit and compare this endpoint between the treatment arms.
Time Frame
Implantation until 12 months follow-up
Title
Change in Silver Serum Levels
Description
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.
Time Frame
Implantation until 12 months follow-up
Title
Proportion of subjects with Treatment emergent adverse events (TEAE)
Description
Investigate the proportion of subjects with TEAEs during the 12-month FU and compare the rate between treatment arms.
Time Frame
Implantation until 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 fibula.
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 chronic soft-tissue and/or bone and/or implant infection signs at the distal tibia and/or distal fibula (not related to current fracture).
Subjects with a possible contraindication for the investigational and comparator devices
infection or inflammation requiring treatment with antibiotics or with positive cultures (not related to current fracture);
acute and chronic osteomyelitis at or close to the surgical field (not related to current fracture);
high anesthesia risk subjects (ASA Physical Status Classification of 4 to 6);
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 childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions according to investigator's judgement can be included.
Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study. Males who are unable or unwilling to use condoms can be included if partners of childbearing potential taking acceptable contraceptive precautions according to investigator's judgement.
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.
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.
14. Subjects with stage IV vascular disease, i.e. with presence of necrotic tissue at the distal tibia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Schoder, Dr.
Phone
+49.30.75019-052
Email
s.schoder@aap.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Lafuente
Phone
+49.30.75019.153
Email
m.lafuente@aap.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Alt, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Alt, Prof. Dr.
Phone
+49 941 944-6805
Email
office.uch@ukr.de
12. IPD Sharing Statement
Plan to Share IPD
No
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LOQTEQ® Antibacterial Pre-Market Study
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