Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Brief Title:
Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Outcomes of Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute Impregnated With Antibiotics Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
- Fischers exact test
Relative Risk
- Cox regression
Descriptive Values
- Mean and standard deviation 95 confidence interval
Statistical Significance
- p 005
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
- Fischers exact test
Relative Risk
- Cox regression
Descriptive Values
- Mean and standard deviation 95 confidence interval
Statistical Significance
- p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None