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World hip trauma evaluation five: a randomised controlled trial comparing cemented and uncemented implants for the treatment of displaced intracapsular hip fractures

A randomised controlled trial to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18393176
Enrollment
1128
Registered
2017-03-16
Start date
2017-03-10
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture Musculoskeletal Diseases Fracture of neck of femur

Interventions

Patients will be randomly assigned a treatment using a web-based randomisation system, this will make sure that about the same number of patients in each participating hospital are assigned each treat

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Feasibility study: All patients, both those with and without capacity, presenting with an AO type 31-B3 (subcapital, displaced, nonimpacted) fracture of the hip Main phase of the study (added 11/04/2018): All patients aged 60 years and older who have fractured their hip and will receive treatment with a hemiarthroplasty

Exclusion criteria

Exclusion criteria: 1. Younger than 60 years of age 2. Managed non-operatively 3. Treated with a total hip replacement

Design outcomes

Primary

MeasureTime frame
Feasibility study: Recruitment rate, calculated from the number of patients screened and recruited at each participating hospital. Logs of screened and recruited patients monitored monthly. Main phase of the study (added 11/04/2018): Quality of life, measured using the EQ-5D-5L score at 4 months post-randomisation

Secondary

MeasureTime frame
Feasibility study: 1. Quality of life, measured using the EQ-5D-5L questionnaire at baseline (retrospective/pre-injury), 1 month and 4 months after surgery 2. Trial feasibility, assessed by analysing the reasons given by potential patients who chose not to participate (or who later withdraw), monitored continuously throughout the trial 3. Changes in blood pressure during and immediately after surgery, calculated from routinely collected blood pressure measurements Main phase of the study (added 11/04/2018): 1. Quality of life, measured using the EQ-5D-5L at 1 and 12 months post randomisation 2. Mortality, measured using routine NHS data at 1, 4 and 12 months post randomisation 3. Functional status, patient-reported during follow-up at 1, 4 and 12 months post randomisation 4. Incidence and cause of revision surgery, patient-reported and from hospital records during follow-up at 12-months post randomisation 5. Complication profile, patient-reported during follow-up at 12-months post randomisation 6. Residential status, patient-reported during follow-up at 1, 4 and 12 months post randomisation 7. Resource use, patient-reported and from hospital records during follow-up at 12-months post randomisation 8. Blood pressure changes during surgery measured using intra-operative haemodynamic measurements at baseline

Countries

England, United Kingdom

Contacts

Public ContactKaty Mironov
white5@ndorms.ox.ac.uk+44 (0)1865 227912

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026