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Status unknownNCT04945434Updated Jun 30, 2021

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

An interventional study of S53P4 bioactive glass (BonAlive) in Osteomyelitis, Bone Infection and Non-Union Fracture, sponsored by Academisch Ziekenhuis Maastricht. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-30.

Sponsored by Academisch Ziekenhuis Maastricht · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 9 years 8 months after the study started (first participant enrolled Sep 2011, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

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Conditions studied

  • 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
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 78 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Academisch Ziekenhuis Maastricht is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    S53P4 BAG intervention group

    Patients recruited and enrolled in study for treatment with S53P4 BAG

    Device: S53P4 bioactive glass (BonAlive)

Interventions

  • DeviceS53P4 bioactive glass (BonAlive)

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

    Also known as: Bonalive bioactive glass

06

What researchers measure

Primary outcomes

  1. Eradication of infection In clinical presentation

    Based on the following Clinical Signs: - Absence of a draining fistula, redness, swelling, pain and fever (\>38,5 degrees of celcius)

    Time frame: 1-5 years follow-up

  2. Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)

    Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 1: - Bone destruction

    Time frame: 1 - 5 years follow-up

  3. Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)

    Radiographic analysis of X-ray or CT images of the affected bone Based on a combination of 2 different infection paramaters Parameter 2: - Periostal reactions

    Time frame: 1 - 5 years follow-up

  4. Eradication of infection in blood sample analysis (1/3)

    Based on a combination of 3 different infection parameters; parameter 1 is C-Reactive protein (\<10mg/L), collected from a venapuncture.

    Time frame: 1 - 5 years follow-up

  5. Eradication of infection in blood sample analysis (2/3)

    Based on a combination of 3 different infection parameters; parameter 2 is Leukocyte count (\<11 x 10E9 cells/L); collected from a venapuncture.

    Time frame: 1 - 5 years follow-up

  6. Eradication of infection in blood sample analysis (3/3)

    Based on a combination of 3 different infection parameters; parameter 3 is Erythrocyte Sedimantation Rate (\<22mm/hour) collected from a venapuncture.

    Time frame: 1 - 5 years follow-up

Secondary outcomes

  1. Complication registration

    Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment

    Time frame: 1-5 years follow-up

Other outcomes

  1. Identification of possible risk factors for failure (1/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 1: - Age at sugery (Years)

    Time frame: Pre-operative value (not time related)

  2. Identification of possible risk factors for failure (2/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 2: - Gender (M/F)

    Time frame: Pre-operative value (not time related)

  3. Identification of possible risk factors for failure (3/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 3: - BMI (kg/m2)

    Time frame: Pre-operative value (not time related)

  4. Identification of possible risk factors for failure (4/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 4: - Smoking (Yes/No)

    Time frame: 1-5 years follow-up

  5. Identification of possible risk factors for failure (5/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 5: - Preoperative Cierny-Mader classification (1/2/3/4)

    Time frame: Pre-operative value (not time related)

  6. Identification of possible risk factors for failure (6/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 6: - Presence of a preoperative fistula (number of patients)

    Time frame: Pre-operative value (not time related)

  7. Identification of possible risk factors for failure (7/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 7: - Mono- vs. Polybacterial peroperative culture (number of patients)

    Time frame: Postoperative value (not time related)

  8. Identification of possible risk factors for failure (8/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 8: - One stage vs. Two stage surgical procedure (number of patients)

    Time frame: Per-operative value (not time related)

  9. Identification of possible risk factors for failure (9/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 9: - Closure of wound by a plastic surgeon (Yes/No)

    Time frame: Per-operative value (not time related)

  10. Identification of possible risk factors for failure (10/10)

    We identified a subset of 10 parameters that might be associated with the possible risk of failure of treatment and will be analyzed. Parameter 10: - Complications (number of patients)

    Time frame: 1-5 years follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04945434
Lead sponsor
Academisch Ziekenhuis Maastricht
Collaborators
University Medical Center Groningen
Responsible party
Tom van Vugt (Principal Investigator, Orthopedic Resident, Academisch Ziekenhuis Maastricht) — Principal investigator
First posted
Jun 30, 2021
Start date
Sep 1, 2011
Primary completion
Jun 30, 2020
Completion
Jun 30, 2021 (estimated)
Last update
Jun 30, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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