HAMLET
Research type
Research Study
Full title
Through knee Amputations impact on Quality of Life compared to Above Knee Amputations - The HAMLET Trial
IRAS ID
330828
Contact name
George Smith
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
Every two hours, someone in the UK has a leg removed and their life is changed forever. When undertaking an amputation, surgeons try and preserve the knee joint if possible. If this is not possible, an above knee amputation is usually performed. However, an amputation through the knee joint is an alternative.
Compared to an above-knee amputation, a through-knee amputation may result in superior outcomes and improved rehabilitation, such as easier control of an artificial leg or balance in a wheelchair, but may also lead to issues with wound healing. Patients report positive and negative experiences with both above and through knee amputations. High quality research is lacking and evidence to clearly define which of these two amputations results in the best outcomes for patients is urgently needed.
HAMLET will compare quality of life, complications, rehabilitation, and cost to the NHS following above and through knee amputations. Adults aged 18-years or older requiring a major lower limb amputation but who are unable to have a below knee amputation will be invited to participate. The study will take place in NHS hospitals that both provide major lower limb amputation care, including the necessary resource and capability to perform both above knee and through knee surgery, and have the facilities to support research activity.
If patients agree to join HAMLET, they will be allocated to have an above or through knee amputation based on chance rather than a patient or surgeon decision. They will have their allocated lower limb amputation and we will follow up the two groups over two years to compare the impact of the amputations on their quality of life, wound healing, re-operations, rehabilitation, walking ability, and the cost to the NHS. Some patients (who provide consent) will be interviewed to assess their views about their amputation.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0007
Date of REC Opinion
20 Jan 2025
REC opinion
Favourable Opinion