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

NCT ID: NCT04945434

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-01
• Study Completion Date: 2021-06-30

Brief 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.

Detailed Description

In this prospective multicenter study, patients from two different university hospitals in the Netherlands were included. Treatment consisted of debridement surgery, implantation of S53P4-BAG, if necessary wound closure by a plastic surgeon and additional culture based systemic antibiotics. Primary outcome was eradication of infection based on clinical presentation, radiographic imaging and laboratory tests. Secondary analysis was performed on probable risk factors for treatment failure after S53P4-BAG implantation.

Conditions

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

Keywords

Bioactive glass; S53P4 BAG; Bonalive; Chronic Osteomyelitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S53P4 BAG intervention group

Patients recruited and enrolled in study for treatment with S53P4 BAG

Group Type: EXPERIMENTAL

S53P4 bioactive glass (BonAlive)

Intervention Type: DEVICE

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

Interventions

S53P4 bioactive glass (BonAlive)

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

Intervention Type: DEVICE

Other Intervention Names

Bonalive bioactive glass

Eligibility Criteria

Inclusion Criteria

• Patients with a clinical, radiographic and/or laboratory study confirmed chronic osteomyelitis of long bones
• Patients who are physically and mentally willing and able to comply with postoperative functional evaluation.
• Patients that can read and understand the Dutch language.

Exclusion Criteria

• Patients with an diabetic ulcer related chronic osteomyelitis
• Patients that are pregnant.
• Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
• Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
• Patients with malignancy - active malignancy within last 1 year
• Patients known with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget's disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
• Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
• Patients with systemic or metabolic disorders leading to progressive bone deterioration
• Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis.
• Patients with a known sensitivity to device materials
• Patients that are an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role: lead

Responsible Party

Tom van Vugt

Principal Investigator, Orthopedic Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Arts, PhD

Role: STUDY_CHAIR

Maastricht Univeristy Medical Centre (MUMC+)

Other Identifiers

MUMC_METC174084

Identifier Type: -

Identifier Source: org_study_id