Back to resultsClinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
Primary Purpose
Osteomyelitis, Bone Infection, Non-Union Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
S53P4 bioactive glass (BonAlive)
Sponsored by
About this trial
This is an interventional treatment trial for Osteomyelitis focused on measuring Bioactive glass, S53P4 BAG, Bonalive, Chronic Osteomyelitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S53P4 BAG intervention group
Arm Description
Patients recruited and enrolled in study for treatment with S53P4 BAG
Outcomes
Primary Outcome Measures
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)
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
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
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.
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.
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.
Secondary Outcome Measures
Complication registration
Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment
Full Information
NCT ID
NCT04945434
First Posted
May 31, 2021
Last Updated
June 22, 2021
Sponsor
Academisch Ziekenhuis Maastricht
Collaborators
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT04945434
Brief Title
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
Official Title
Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2011 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Ziekenhuis Maastricht
Collaborators
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S53P4 BAG intervention group
Arm Type
Experimental
Arm Description
Patients recruited and enrolled in study for treatment with S53P4 BAG
Intervention Type
Device
Intervention Name(s)
S53P4 bioactive glass (BonAlive)
Other Intervention Name(s)
Bonalive bioactive glass
Intervention Description
Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.
Primary Outcome Measure Information:
Title
Eradication of infection In clinical presentation
Description
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
Title
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
Description
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
Title
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
Description
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
Title
Eradication of infection in blood sample analysis (1/3)
Description
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
Title
Eradication of infection in blood sample analysis (2/3)
Description
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
Title
Eradication of infection in blood sample analysis (3/3)
Description
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 Outcome Measure Information:
Title
Complication registration
Description
Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment
Time Frame
1-5 years follow-up
Other Pre-specified Outcome Measures:
Title
Identification of possible risk factors for failure (1/10)
Description
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)
Title
Identification of possible risk factors for failure (2/10)
Description
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)
Title
Identification of possible risk factors for failure (3/10)
Description
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)
Title
Identification of possible risk factors for failure (4/10)
Description
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
Title
Identification of possible risk factors for failure (5/10)
Description
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)
Title
Identification of possible risk factors for failure (6/10)
Description
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)
Title
Identification of possible risk factors for failure (7/10)
Description
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)
Title
Identification of possible risk factors for failure (8/10)
Description
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)
Title
Identification of possible risk factors for failure (9/10)
Description
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)
Title
Identification of possible risk factors for failure (10/10)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Arts, PhD
Organizational Affiliation
Maastricht Univeristy Medical Centre (MUMC+)
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
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