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Clinical 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
Academisch Ziekenhuis Maastricht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteomyelitis focused on measuring Bioactive glass, S53P4 BAG, Bonalive, Chronic Osteomyelitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    May 31, 2021
    Last Updated
    June 22, 2021
    Sponsor
    Academisch Ziekenhuis Maastricht
    Collaborators
    University Medical Center Groningen
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    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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