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Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis

NCT04945434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-06-30

No results posted yet for this study

Summary

This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.

Conditions

  • Osteomyelitis
  • Bone Infection
  • Non-Union Fracture
  • Bone Infection of Lower Leg
  • Bone Infection of Pelvis, Hip, or Femur

Interventions

DEVICE

S53P4 bioactive glass (BonAlive)

Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Academisch Ziekenhuis Maastricht

    lead OTHER

Principal Investigators

  • Chris Arts, PhD · Maastricht Univeristy Medical Centre (MUMC+)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-01
Primary Completion
2020-06-30
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945434 on ClinicalTrials.gov