Hip fracture Surgery Fracture of hip NOS
Conditions
Interventions
Participants will undergo surgery at the next available opportunity on a planned trauma list. Participants will be blinded to the treatment allocation. The operating surgeon will not be blinded to the
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 60 years or older 2. Intracapsular hip fracture, which in the opinion of the treating surgeon requires acute surgical treatment with a cemented hip hemiarthroplasty
Exclusion criteria
Exclusion criteria: Patients will be excluded if they are allergic to gentamicin or clindamycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deep Infection of surgical wound; the trialists will use the Centre for Disease Control and Prevention definition of a “deep surgical site infection”, that is a wound infection involving the tissues deep to the skin that occurs within 90 days of injury. Medical records for all patients will be reviewed by appropriately trained staff for indicators of infection at the time of the patient’s discharge from the research site. In addition, at 120 days post-surgery, the patients will self-report (via telephone interview, electronic media or postal questionnaire) on signs of infections. When potential signs of infection have been found, either at discharge or 120 days, the site will be asked to provide, if available, copies of: any re-operation records for surgery related to the index hip fracture, details of antibiotics prescribed, microbiology reports if samples of the suspected infected tissues around the hip were sent for analysis and imaging reports for any deep imaging that occurred in relation to suspected infection. These data will be collated by the central trial team in Oxford. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality recorded at discharge from the research site as well as in the 120-day follow-up. Sites or consultees may also report mortality at any point in the time between discharge and 120 days. 2. Health-related quality of life measured by EuroQol EQ-5D-5L at baseline and at 120 days post-surgery 3. All complications and surgical interventions related to the index wound will be recorded. These are reported by sites as they become aware of events, as well as by patients, carers or consultees at 4 months (120 days) 4. Antibiotic prescription information will be obtained from the patient, consultee or carer at the 4 months (120 days) follow-up. Should the patient be entered into the trial under nominated consultee agreement and this information not be available from a carer, the trial team may contact the patient’s GP for this information 5. Resistance patterns of infections; all infections identified in the primary endpoint will be assessed for antibiotic resistance profiles by the local microbiology team 6. Resource use; cost data will be obtained from national databases or will be estimated in consultation with the hospital finance department. The cost consequences following discharge, including NHS costs and patients' out-of-pocket expenses will be recorded via a short questionnaire, which will be administered at 4 months (120 days) post-surgery. This will be either by patient or consultee 7. Mobility; the ability to walk indoors and outdoors is rated very highly by patients. It has been included in a recommended ‘core outcome set’ for trials assessing interventions in hip fractures, hence it will be recorded using the CRF. It will be captured at baseline and at 4 months (120 days). 8. Residential status; also captured on CRF. The residential status is also part of the core outcome set for hip fractures and NHFD dataset. It will be captured at baseline and at 4 months (120 days) | — |
Countries
England, United Kingdom, United States of America, Wales
Outcome results
None listed