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| Name | Class |
|---|---|
| BONESUPPORT AB | INDUSTRY |
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The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:
• How does the bone infection heal in response to the antibiotic paste?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerament | Experimental | Cerament V/G implantation to forefoot or mid foot. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerament V or G | Device | Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no) | Clinical osteomyelitis: positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end. Radiological osteomyelitis: osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s). This is checked at each follow up visit, at 1, 6 and 12 months post-implantation. | 12 months post-implantion |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection requiring further course of antibiotics (recorded as yes or no) | If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded. | 12 months post-implantion |
| Major or minor amputation of study limb (recorded as yes or no with amputation details) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nishita R Gadi | Contact | +441268 524900 | nishita.gadi1@nhs.net | |
| Georgina Beeter | Contact | Georgina.Beetar@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Ankur Thapar | Mid and South Essex NHS Foundation Trust | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39182821 | Background | Venkateswaran V, Tiruveedhula M, Edwards J, Dindyal S, Mulcahy M, Thapar A. Antibiotic Eluting Bone Void Filler Versus Systemic Antibiotics For Pedal Osteomyelitis. J Foot Ankle Surg. 2025 Jan-Feb;64(1):30-35. doi: 10.1053/j.jfas.2024.08.010. Epub 2024 Aug 23. |
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Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
01/11/2026 to 1/11/2036
Ankur Thapar
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| ID | Term |
|---|---|
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Case Series
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If major or minor amputation of study limb occurs, this will be recorded. |
| 12 months post-implantion |
| Serious adverse events related to Cerament V/G (number and type of event are recorded) | A serious adverse event (SAE) refers to any expected or unexpected adverse event, related to ceramist, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalisation (not required as part of the treatment) or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect. | 12 months post implantation |
| Total treatment costs for osteomyelitis (total cost is calculated in GB pounds) | Treatment costs will be collected through the use of a Client Service Research Inventory focussed on surgical, community and further treatment costs over a 12 month follow up. These will be recorded by the patient as they occur and checked at each visit and cross reference with hospital medical records. | 12 months post-implantation |
| Wound healing (recorded as yes or no) | Wound is considered healed at 100% epithelialisation. This is checked at each follow up visit, at 1, 6 and 12 months post-implantation. | 12 months post-implantation |
| Wound area (measured in cm^2) | Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure. | 12 months post-implantation |
| Quality of life (measured using the EQ-5D questionnaire) | Quality of life is measured using the EQ-5D questionnaire. It is conducted at each follow up visit, at 1, 6 and 12 months post-implantation. | 12 months post-implantation |