Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06402292 |
| Other study ID # |
FALOTICO |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2024 |
| Est. completion date |
February 28, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Federal University of São Paulo |
| Contact |
GUILHERME FALOTICO, PhD |
| Phone |
5511988403831 |
| Email |
falotico[@]unifesp.br |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This prospective research project aims to evaluate the effectiveness and clinical outcomes of
utilizing antibiotic-impregnated bioactive bone substitute (PerOssal®) in the surgical
management of osteoarticular infections. Osteoarticular infections pose significant
challenges in orthopaedic surgery due to the risk of persistent infection, bone loss, and
functional impairment. Traditional treatment approaches involve extensive debridement
followed by systemic antibiotic therapy and bone grafting. However, antibiotic-impregnated
bioactive bone substitutes offer a promising alternative by providing local antibiotic
delivery and promoting bone regeneration simultaneously. This study will prospectively enrol
patients undergoing surgical intervention for osteoarticular infections and assess their
clinical outcomes, including infection resolution, bone healing, functional recovery, and
complication rates. Comprehensive data collection will include preoperative patient
characteristics, intraoperative details, postoperative outcomes, and long-term follow-up
assessments. Statistical analyses will be performed to compare outcomes between patients
treated with antibiotic-impregnated bioactive bone substitute and those past managed with
traditional methods. The findings of this study are expected to contribute valuable insights
into the effectivennes and safety of this novel approach, potentially informing future
clinical practices and optimizing patient care in the management of osteoarticular
infections.
Description:
Background:
Osteoarticular infections represent a significant challenge in orthopedic surgery, posing
substantial morbidity and potential mortality if not adequately managed. These infections can
arise from various sources, including hematogenous spread, contiguous spread from adjacent
soft tissue or bone, or direct inoculation during trauma or surgery. Common pathogens
associated with osteoarticular infections include Staphylococcus aureus, coagulase-negative
staphylococci, Streptococcus species, and gram-negative bacilli, among others.
The management of osteoarticular infections typically involves a combination of surgical
intervention and antimicrobial therapy. Surgical treatment aims to achieve complete
debridement of infected tissue, removal of necrotic bone, and restoration of skeletal
integrity. However, achieving adequate debridement and local antibiotic delivery while
preserving bone stock remains a challenge.
Traditional approaches to bone defect management often rely on autografts, allografts, or
synthetic bone substitutes. While these methods have demonstrated efficacy in promoting bone
healing, they may not address the specific challenges posed by osteoarticular infections,
particularly in terms of infection eradication and local antibiotic delivery.
In recent years, there has been growing interest in the use of antibiotic-impregnated
bioactive bone substitutes for the management of osteoarticular infections. These materials
offer several potential advantages over traditional approaches. Firstly, they provide a
scaffold for bone regeneration, promoting osteogenesis and osteoconduction. Secondly, they
have the capacity to release antibiotics locally, achieving high concentrations at the site
of infection while minimizing systemic exposure and potential adverse effects. Thirdly, they
can fill osseous defects and provide structural support, facilitating functional recovery.
The efficacy of antibiotic-impregnated bioactive bone substitutes in the treatment of
osteoarticular infections has been investigated in several preclinical and clinical studies.
Preclinical studies have demonstrated the ability of these materials to effectively deliver
antibiotics, inhibit bacterial growth, and promote bone healing in animal models of
osteomyelitis and septic arthritis. Clinical studies have reported promising results,
including high rates of infection resolution, bone healing, and functional recovery, with low
rates of recurrence and complications.
However, despite these promising findings, there remains a need for further research to
evaluate the long-term outcomes and comparative effectiveness of antibiotic-impregnated
bioactive bone substitutes in the surgical management of osteoarticular infections.
Additionally, questions regarding the optimal selection of antibiotics, the timing and
duration of local antibiotic delivery, and the potential for antibiotic resistance warrant
investigation.
Therefore, this prospective research project aims to address these gaps in knowledge by
evaluating the outcomes of surgical treatment of osteoarticular infections using
antibiotic-impregnated bioactive bone substitutes in a well-defined patient population. By
systematically assessing clinical outcomes, including infection resolution, bone healing,
functional recovery, and complication rates, this study seeks to provide evidence-based
insights into the efficacy and safety of this novel approach. Ultimately, the findings of
this study may have implications for clinical practice, guiding the optimization of surgical
management strategies for osteoarticular infections and improving patient outcomes.
Hypothesis The utilization of antibiotic-impregnated bioactive bone substitute reduces
recurrence in patients with osteoarticular infections compared to untreated patients. It
presents clinical non-inferiority and decreases hospitalization time in relation to the use
of PMMA, as it does not require another surgical procedure for material removal.
Clinical Question:
PICOS Strategy P (Patients): Patients above 12 years old with fracture-related infection
(FRI) and indication for surgical treatment.
I (Intervention): Orthopedic surgical treatment with standard local debridement, supplemented
with implantation of antibiotic-impregnated bioactive bone substitute (PerOssal®).
C (Control): Retrospective cohort of previously operated patients without the use of local
treatment or with the use of antibiotic-loaded PMMA.
O (Outcomes):
Primary: Comparative rate of infection recurrence within 1-year follow-up. Secondary: Pain
score, quality of life, overall complications, microbiological profile of infections,
duration of systemic antibiotic usage, length of hospital stay.
S (Study): Prospective cohort.
Methods:
This is an observational, prospective, single-center study. The methodology will be guided by
the STROBE checklist and the study submitted to the Plataforma Brasil and Ethics Committee.
Data will be collected using RedCap® Protocol.
Sample size calculation: For comparison of relative risk between groups, expecting a mean
difference of 20% in infection recurrence rate between patients without local antibiotic
treatment and patients with local treatment, the expected necessary number of patients is 20.
Accounting for a 20% loss to follow-up, the required number of patients in the study will be
25.
Statistical Analysis:
Quantitative Variables:
- T-test and ANOVA for parametric data.
- Mann-Whitney or Kruskal-Wallis tests for non-parametric data.
Qualitative Variables:
- Fischer's exact test.
Relative Risk:
- Cox regression.
Descriptive Values:
- Mean and standard deviation; 95% confidence interval.
Statistical Significance:
- p < 0.05.
