WHiTE Five - Main Study
Research type
Research Study
Full title
A randomised controlled trial comparing contemporary uncemented hemiarthroplasty with standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures.
IRAS ID
233958
Contact name
Matthew Costa
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Summary of Research
Hip fracture is a serious injury which mostly occurs in older patients. In the UK there are ~60,000 hip fractures every year. A hip fracture is a potentially catastrophic event; approximately 30% of patients will die during the first year following this injury and those that survive will have a significant reduction in their quality of life. The most common type of hip fracture is treated with a partial hip replacement. The implant can be fixed to the patient’s thigh bone with or without the use of ‘bone cement’. Cement is the current standard technique, but there are some risks with bone cement which could be avoided by using ‘uncemented’ implants. These risks, which include an increase in mortality during the first 24 hours after surgery, have prompted an alert from the National Patient Safety Agency.
Historically, the outcomes with early uncemented implants were shown to be inferior to the cemented implants currently used, and this has been the justification for the ongoing use of cement. However, since these studies were done, there have been significant improvements in uncemented implant technology and the current, although limited, evidence suggests that these modern uncemented implants may be as good as the cemented implants but without the risks of using cement.
This study will be a randomised controlled trial in 1128 participants that will answer the question of whether outcomes with modern uncemented stems are comparable to the cemented stems currently used in the majority of UK centres. Eligible patients will be aged 60 years and over who have sustained a hip fracture which is suitable for a hemiarthroplasty. We will include participants with cognitive impairment. After consent or consultee agreement participants will be randomised to receive either a modern uncemented implant or a cemented implant.
In this study, we will primarily assess the distribution of quality of life scores, along with details of participants’ mobility and residential status. The demographic and treatment details along with pre-injury quality of life will be assessed at baseline, and quality of life will be assessed again 1-month and 4-months after the injury.
Summary of Results
Hip fracture in older people is a huge problem which significantly impacts health-related quality of life for patients and places a large socioeconomic burden upon healthcare systems. Around the world, there are expected to be 6.26 million hip fractures per year by 2050.
Approximately half of hip fractures occur at the neck of the femur (thigh bone) and are usually treated with a partial hip replacement in which the head of the femur is replaced with a metal implant (hemiarthroplasty).
There is controversy about how best to fix the hemiarthroplasty implant to the bone of the femur. If the implant is not securely bonded to the patient’s bone it can loosen causing pain and restricting movement and activities of daily living.
Previous evidence showed that implants fixed with bone cement (cemented hemiarthroplasty) are superior to the first generation of ‘press-fit’ uncemented implants. However, modern uncemented implants have been redesigned with special surface coatings to provide more reliable bonding between the implant and the bone. Data from hospital implant registries shows that modern uncemented hemiarthroplasty is becoming increasingly popular around the world despite little evidence that it provides better outcomes for patients.
We performed the WHiTE 5 trial to compare health-related quality of life in adults over 60 years of age with a hip fracture who were randomly allocated to either a modern uncemented hemiarthroplasty or cemented hemiarthroplasty.
Conclusion
Among people 60 years or over with a fracture of the hip, cemented hemiarthroplasty provided better quality of life than modern uncemented hemiarthroplasty. The study also showed that cemented hemiarthroplasty is safe with no increase in the risk of death and a lower risk of further fracture around the hip implant.REC name
Wales REC 5
REC reference
17/WA/0383
Date of REC Opinion
22 Nov 2017
REC opinion
Favourable Opinion