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

A

Academisch Ziekenhuis Maastricht

Status

Unknown

Conditions

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

Treatments

Device: S53P4 bioactive glass (BonAlive)

Study type

Interventional

Funder types

Other

Identifiers

NCT04945434
MUMC_METC174084

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

S53P4 BAG intervention group
Experimental group
Description:
Patients recruited and enrolled in study for treatment with S53P4 BAG
Treatment:
Device: S53P4 bioactive glass (BonAlive)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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