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NCT Number: NCT06628115

Post Market Study of Cerament V/G in Pedal Osteomyelitis

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:

* Undergo standard surgery to remove dead bone and drain any pus. * Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks. * Recieve one week of tablet antibiotics. * Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire. * Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.

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Key information

Conditions

Osteomyelitis - Foot Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases Osteomyelitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years +
  • Informed consent
  • Operated on for foot sepsis with limb salvage intent.
  • Positive bone biopsy from forefoot or midfoot or positive pus culture from exposed bone
  • Adequate vascularity (1+ palpable pedal pulse, biphasic or triphasic ankle waveforms, or successful revascularisation procedure same admission)
  • Compliant with offloading footwear and diabetic medication

Exclusion criteria

  • Allergy or contraindication to gentamicin/vancomycin
  • Life expectancy &amp <1 year
  • Unable to make follow up appointments at study centre.
  • Patients with necrotizing infections
  • Gentamicin or vancomycin resistant organism
  • Untreated peripheral arterial disease in angiosome of wound.
  • Buerger's disease
  • Vasculitides
  • Systemic immunosuppressive therapy
  • Pregnancy
  • Breastfeeding
  • Untreated thyrotoxicosis
  • Mysathenia gravis
  • Calcium metabolism disorder
  • Patients taking metformin with estimated glomerular filtration rate (eGFR) > 30ml/min/1.72m2

Treatment and study plan

cerament V or G

Device

Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.

Primary outcomes

  1. Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)

    Time frame: 12 months post-implantion

    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.

Secondary outcomes

  1. Surgical site infection requiring further course of antibiotics (recorded as yes or no)

    Time frame: 12 months post-implantion

    If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded.

  2. Major or minor amputation of study limb (recorded as yes or no with amputation details)

    Time frame: 12 months post-implantion

    If major or minor amputation of study limb occurs, this will be recorded.

  3. Serious adverse events related to Cerament V/G (number and type of event are recorded)

    Time frame: 12 months post implantation

    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.

  4. Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)

    Time frame: 12 months post-implantation

    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.

  5. Wound healing (recorded as yes or no)

    Time frame: 12 months post-implantation

    Wound is considered healed at 100% epithelialisation. This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.

  6. Wound area (measured in cm^2)

    Time frame: 12 months post-implantation

    Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure.

  7. Quality of life (measured using the EQ-5D questionnaire)

    Time frame: 12 months post-implantation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgina Beeter

CONTACT

[email protected]

Nishita R Gadi

CONTACT

[email protected]

+441268 524900

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Collaborators

  • BONESUPPORT AB

Registry information

Official study title

Post-market Study of Cerament V/G in Foot Osteomyelitis

Acronym: Cerament 2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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