NCT06402292

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

April 30, 2024

Last Update Submit

May 2, 2024

Conditions

OsteomyelitisInfectionsFractureAntibiotics

Keywords

infectionosteomyelitisfracturelocal antibiotics

Outcome Measures

Primary Outcomes (1)

  • Comparative rate of infection recurrence

    1 YEAR

Secondary Outcomes (6)

  • Pain score using numeric pain scale (0 - no pain; 10 - worst pain)

    6,12, 24, 48 WEEKS

  • QUALITY OF LIFE USING EuroQol-5D (EQ-5D)

    6,12, 24, 48 WEEKS

  • General complications (other than infection recurrence)

    6,12, 24, 48 WEEKS

  • Microbiological profile of infections

    up to 1 week

  • Duration of systemic antibiotic usage

    up to 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

PATIENTS WITH FRACTURE-RELATED INFECTION (FRI GROUP)

EXPERIMENTAL

USE OF LOCAL ANTIBIOTICS WITH PEROSSAL

Procedure: OSTEOMYELITIS SURGICAL TREATMENT WITH LOCAL ANTIBIOTICS AND PEROSSAL

Interventions

OSTEOMYELITIS SURGICAL TREATMENT WITH LOCAL ANTIBIOTICS AND PEROSSALPROCEDURE

25 PATIENTS WITH FRI WILL BE SURGICALLY TREAT WITH DESBRIDMENT AND PEROSSAL WITH ANTIBIOTCS

PATIENTS WITH FRACTURE-RELATED INFECTION (FRI GROUP)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All fracture-related infections (clinical and laboratory/microbiological diagnosis).
  • Patients \> 12 years old.
  • Surgical treatment with indication for local antibiotic use.

You may not qualify if:

  • Other modalities of musculoskeletal infection (arthroplasties, hematogenous osteomyelitis, septic arthritis, infections related to bone tumors).
  • Unconfirmed diagnosis of infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteomyelitisInfectionsFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousBone DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • GUILHERME FALOTICO, PhD

    PROFESSOR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GUILHERME FALOTICO, PhD

CONTACT

5511988403831falotico@unifesp.br

MARCUS LUZO, PROFESSOR

CONTACT

+55115576-4848luzo@unifesp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 7, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share