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

Osteomyelitis Clinical Trial

Official title:

Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04945434
• Other study ID #: MUMC_METC174084
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2011
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: Academisch Ziekenhuis Maastricht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Infection
• Communicable Diseases
• Fractures, Ununited
• Infection
• Non-Union Fracture
• Osteomyelitis

Intervention

Device:
• S53P4 bioactive glass (BonAlive)
Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht	University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Complication registration	Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment	1-5 years follow-up