Clinical trial NCT04945434: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2021-06-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group cohort study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eradication of infection In clinical presentation
timeFrame: 1-5 years follow-up
measure: Absence of signs of chronic osteomyelitis on radiographic imaging (1/2)
timeFrame: 1 - 5 years follow-up
measure: Absence of signs of chronic osteomyelitis on radiographic imaging (2/2)
timeFrame: 1 - 5 years follow-up
measure: Eradication of infection in blood sample analysis (1/3)
timeFrame: 1 - 5 years follow-up
measure: Eradication of infection in blood sample analysis (2/3)
timeFrame: 1 - 5 years follow-up
measure: Eradication of infection in blood sample analysis (3/3)
timeFrame: 1 - 5 years follow-up
Secondary outcomes:
measure: Complication registration
timeFrame: 1-5 years follow-up
Other outcomes:
measure: Identification of possible risk factors for failure (1/10)
timeFrame: Pre-operative value (not time related)
measure: Identification of possible risk factors for failure (2/10)
timeFrame: Pre-operative value (not time related)
measure: Identification of possible risk factors for failure (3/10)
timeFrame: Pre-operative value (not time related)
measure: Identification of possible risk factors for failure (4/10)
timeFrame: 1-5 years follow-up
measure: Identification of possible risk factors for failure (5/10)
timeFrame: Pre-operative value (not time related)
measure: Identification of possible risk factors for failure (6/10)
timeFrame: Pre-operative value (not time related)
measure: Identification of possible risk factors for failure (7/10)
timeFrame: Postoperative value (not time related)
measure: Identification of possible risk factors for failure (8/10)
timeFrame: Per-operative value (not time related)
measure: Identification of possible risk factors for failure (9/10)
timeFrame: Per-operative value (not time related)
measure: Identification of possible risk factors for failure (10/10)
timeFrame: 1-5 years follow-up
Locations:
Study officials:
affiliation: Maastricht Univeristy Medical Centre (MUMC+)
name: Chris Arts, PhD
role: STUDY_CHAIR
References: