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

Not Applicable

• Conditions: Osteomyelitis; Bone Infection; Non-Union Fracture; Bone Infection of Lower Leg; Bone Infection of Pelvis, Hip, or Femur
• Interventions: Device: S53P4 bioactive glass (BonAlive)

• Registration Number: NCT04945434
• Lead Sponsor: Academisch Ziekenhuis Maastricht

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.

Study Timeline

• Study Start: 2011-09-01
• Primary Completion: 2020-06-30
• Study First Submitted: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study Completion: 2021-06-30
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S53P4 BAG intervention group	S53P4 bioactive glass (BonAlive)	Patients recruited and enrolled in study for treatment with S53P4 BAG

Primary Outcome Measures

Name	Time	Method
Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)	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 clinical presentation	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)
Eradication of infection in blood sample analysis (1/3)	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.
Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)	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
Eradication of infection in blood sample analysis (3/3)	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.
Eradication of infection in blood sample analysis (2/3)	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.

Secondary Outcome Measures

Name	Time	Method
Complication registration	1-5 years follow-up	Number of patients with adverse reactions or events related to S53P4 bioactive glass treatment