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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteomyelitis; Bone Infection; Non-Union Fracture; Bone Infection of Lower Leg; Bone Infection of Pelvis, Hip, or Femur
• Intervention / Treatment: Device: S53P4 bioactive glass (BonAlive)

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S53P4 BAG intervention group; Patients recruited and enrolled in study for treatment with S53P4 BAG	Device: S53P4 bioactive glass (BonAlive); Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.; Other Names: Bonalive bioactive glass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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.	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.	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.	1 - 5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication registration	Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment	1-5 years follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Pre-operative value (not time related)
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)	Pre-operative value (not time related)
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)	Pre-operative value (not time related)
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)	1-5 years follow-up
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)	Pre-operative value (not time related)
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)	Pre-operative value (not time related)
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)	Postoperative value (not time related)
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)	Per-operative value (not time related)
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)	Per-operative value (not time related)
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)	1-5 years follow-up

Collaborators and Investigators

• Sponsor: Academisch Ziekenhuis Maastricht
• Collaborators: University Medical Center Groningen
• Investigators: Study Chair: Chris Arts, PhD, Maastricht Univeristy Medical Centre (MUMC+)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): June 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Bioactive glass; Bonalive; S53P4 BAG; Chronic Osteomyelitis
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Infections; Communicable Diseases; Fractures, Ununited; Pelvic Infection; Osteomyelitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: MUMC_METC174084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No