OsteomyelitisNCT04945434
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
A study testing S53P4 bioactive glass (BonAlive) in people with Osteomyelitis and Bone Infection, run by Academisch Ziekenhuis Maastricht.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Bone Infection, Non-Union Fracture
- What is being tested?
- S53P4 bioactive glass (BonAlive)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study
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.
- Conditions
- Osteomyelitis, Bone Infection, Non-Union Fracture, Bone Infection of Lower Leg, Bone Infection of Pelvis, Hip, or Femur
- Being tested
- S53P4 bioactive glass (BonAlive)
- Keywords
- Bioactive glass, S53P4 BAG, Bonalive, Chronic Osteomyelitis
- Medical subject headings
- Osteomyelitis, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S53P4 bioactive glass (BonAlive)Device
Also called Bonalive bioactive glass
Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.
| Study group | Role | What they receive |
|---|---|---|
| S53P4 BAG intervention group | Experimental | Patients recruited and enrolled in study for treatment with S53P4 BAG Receives: Device: S53P4 bioactive glass (BonAlive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1-5 years follow-up
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
Measured: 1 - 5 years follow-up
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
Measured: 1 - 5 years follow-up
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.
Measured: 1 - 5 years follow-up
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.
Measured: 1 - 5 years follow-up
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.
Measured: 1 - 5 years follow-up
Secondary outcomes (1)
Complication registration
Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment
Measured: 1-5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Sep 2011
- Primary completion30 Jun 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group cohort study
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Tom van Vugt, Academisch Ziekenhuis Maastricht
- Investigators
- Chris Arts, PhD, Study chair, Maastricht Univeristy Medical Centre (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945434
- Sponsor's protocol ID
- MUMC_METC174084
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study
- ClinicalTrials.gov ID
- NCT04945434
- Acronym / sponsor ID
- MUMC_METC174084
- 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 type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group cohort study
| Arm | Type | Receives |
|---|---|---|
| S53P4 BAG intervention group | Experimental | Device: S53P4 bioactive glass (BonAlive)Patients recruited and enrolled in study for treatment with S53P4 BAG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S53P4 bioactive glass (BonAlive)Also: Bonalive bioactive glassSurgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis. | Device | S53P4 BAG intervention group |
Primary outcome
Eradication of infection In clinical presentation
Time frame: 1-5 years follow-up
Based on the following Clinical Signs: - Absence of a draining fistula, redness, swelling, pain and fever (>38,5 degrees of celcius)
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
Time frame: 1 - 5 years follow-up
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
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
Time frame: 1 - 5 years follow-up
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
Eradication of infection in blood sample analysis (1/3)
Time frame: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 1 is C-Reactive protein (<10mg/L), collected from a venapuncture.
Eradication of infection in blood sample analysis (2/3)
Time frame: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 2 is Leukocyte count (<11 x 10E9 cells/L); collected from a venapuncture.
Eradication of infection in blood sample analysis (3/3)
Time frame: 1 - 5 years follow-up
Based on a combination of 3 different infection parameters; parameter 3 is Erythrocyte Sedimantation Rate (<22mm/hour) collected from a venapuncture.
1 secondary outcome
Complication registration
Time frame: 1-5 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Arts, PhD study chair
Maastricht Univeristy Medical Centre (MUMC+)
Questions about this trial
What is this clinical trial studying?
A study testing S53P4 bioactive glass (BonAlive) in people with Osteomyelitis and Bone Infection, run by Academisch Ziekenhuis Maastricht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of infection In clinical presentation (time frame: 1-5 years follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.