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

NCT04945434 | Unknown

• 1 other identifier: MUMC_METC174084
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Complication registration

  1-5 years follow-up

Other Outcomes (10)

• Identification of possible risk factors for failure (1/10)

  Pre-operative value (not time related)

• Identification of possible risk factors for failure (2/10)

  Pre-operative value (not time related)

• Identification of possible risk factors for failure (3/10)

  Pre-operative value (not time related)

Study Arms (1)

S53P4 BAG intervention group

EXPERIMENTAL

Patients recruited and enrolled in study for treatment with S53P4 BAG

Device: S53P4 bioactive glass (BonAlive)

Interventions

S53P4 bioactive glass (BonAlive) DEVICE

Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.

Also known as: Bonalive bioactive glass

S53P4 BAG intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead
• University Medical Center Groningen: collaborator

MeSH Terms

Conditions

Osteomyelitis; Fractures, Ununited

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• Chris Arts, PhD

  Maastricht Univeristy Medical Centre (MUMC+)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopedic Resident

Model Details: Single group cohort study

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 30, 2021
• Study Start: September 1, 2011
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06