Cerament study
Research type
Research Study
Full title
A single-centre retrospective parallel 2 group cohort study of patients treated with antibiotic impregnated bone cement for foot osteomyelitis.
IRAS ID
304632
Contact name
Ankur Thapar
Contact email
Sponsor organisation
Mid and South Essex NHS Foundation Trust
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Patients with uncontrolled osteomyelitis requiring surgery currently face an extremely high major and minor amputation rate. After revascularisation, bone infection is poorly treated with intravenous antibiotics alone, leading to high rates of recurrence and long term intravenous antibiotics therapy and amputaiton. New developments such as antibiotic impregnated bone cement allow bone protection from fracture and much higher local antibiotic concentrations for 28 days than intravenous therapy alone. This may facilitate reduced rates of recurrent osteomyelitis and avoidance of long term intravenous systemic antiobiotic therapy through a central cannula.
This is a single centre retrospective parallel group observational study comparing two contemporary groups treated with intravenous antibiotics (control group) versus antibiotic impregnated bone cement plus oral antibiotics (Cerament group) for osteomyelitis. The primary endpoint is recurrence of clinical osteomyelitis. The secondary endpoints are limb salvage, wound healing and duration of outpatient intravenous antibiotic therapy.
REC name
London - Stanmore Research Ethics Committee
REC reference
22/PR/0813
Date of REC Opinion
7 Jul 2022
REC opinion
Further Information Favourable Opinion