Through knee amputation compared to above knee amputation

Through knee amputations impact on quality of life compared to above knee amputations - the HAMLET trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28683499

Enrollment

386

Registered

2025-02-18

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Major lower limb amputation Surgery

Interventions

Eligible and consenting patients will be randomly allocated to either a through knee amputation or above knee amputation. Participants will be informed of their treatment allocation. As part of the r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Requiring unilateral major lower limb amputation (MLLA), including patients with a pre-existing below knee amputation (BKA) who require revision to a through knee (TKA) or above knee amputation (AKA) 3. Able to provide consent and willing to adhere to the follow-up protocol

Exclusion criteria

Exclusion criteria: 1. Suitable for a BKA – as determined by the local surgical team 2. Contraindication to either AKA or TKA – as determined by the local surgical team 3. Limited life expectancy (of =6 months) 4. Patients who require concurrent bilateral MLLA 5. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires 6. Previously recruited to the HAMLET Trial

Design outcomes

Primary

Measure	Time frame
Quality of life (QoL) measured using the EuroQol 5 Dimensions (5L) score (EQ5D-5L) via remote questionnaire (telephone, electronic or postal) at 24 months post-randomisation	—

Secondary

Measure	Time frame
Surgical outcomes: 1. Perioperative blood loss assessed using the Riddle formula alongside details of any products used in the perioperative period as documented in clinical notes 2. Planned or unplanned high observation or intensive care admission, assessed from the clinical notes at discharge 3. Procedural pain documented on a 0-10 numerical rating scale at baseline and over the first 5 days post-procedure 4. Within-hospital complications, specifically major adverse cardiovascular events, renal impairment and delirium, assessed from the clinical notes and recorded at the time of discharge 5. Impaired wound healing (including wound infection), assessed from the clinical notes and recorded at the time of discharge 6. Returns to theatre: requirement for revision surgery at either the same or a higher level of amputation, assessed from the clinical notes at discharge, 4, 8, 12, 16, 20 and 24 months 7. 30-day mortality assessed from the clinical notes 8. Total inpatient length of stay assessed from the clinical notes 9. Days alive and out of hospital (measured at 90 days) assessed from the clinical notes 10. Discharge destination, determined from discharge clinical notes and recorded as own home/rehab facility/respite facility/residential care/nursing care 11. Contralateral limb outcomes (minor/major amputation), self-reported at telephone follow-up or assessed from clinical notes at 4, 8, 12, 16, 20 and 24 months Rehabilitation outcomes: 1. Early mobility measured using the completion of the Basic Amputee Mobility Score (BAMS) by the participants' clinical team at 5 days post-procedure 2. Prosthesis assessment measured using the Special Interest Group in Amputee Medicine Score (SIGAM), assessed from clinical notes review at discharge from hospital and discharge from rehabilitation 3. Referral or not referred for prosthetic assessment assessed from clinical notes during physiotherapy assessment (Note - there is no set timepoint for this assessment. A decision will be	—

Measure

Time frame

Surgical outcomes: 1. Perioperative blood loss assessed using the Riddle formula alongside details of any products used in the perioperative period as documented in clinical notes 2. Planned or unplanned high observation or intensive care admission, assessed from the clinical notes at discharge 3. Procedural pain documented on a 0-10 numerical rating scale at baseline and over the first 5 days post-procedure 4. Within-hospital complications, specifically major adverse cardiovascular events, renal impairment and delirium, assessed from the clinical notes and recorded at the time of discharge 5. Impaired wound healing (including wound infection), assessed from the clinical notes and recorded at the time of discharge 6. Returns to theatre: requirement for revision surgery at either the same or a higher level of amputation, assessed from the clinical notes at discharge, 4, 8, 12, 16, 20 and 24 months 7. 30-day mortality assessed from the clinical notes 8. Total inpatient length of stay assessed from the clinical notes 9. Days alive and out of hospital (measured at 90 days) assessed from the clinical notes 10. Discharge destination, determined from discharge clinical notes and recorded as own home/rehab facility/respite facility/residential care/nursing care 11. Contralateral limb outcomes (minor/major amputation), self-reported at telephone follow-up or assessed from clinical notes at 4, 8, 12, 16, 20 and 24 months Rehabilitation outcomes: 1. Early mobility measured using the completion of the Basic Amputee Mobility Score (BAMS) by the participants' clinical team at 5 days post-procedure 2. Prosthesis assessment measured using the Special Interest Group in Amputee Medicine Score (SIGAM), assessed from clinical notes review at discharge from hospital and discharge from rehabilitation 3. Referral or not referred for prosthetic assessment assessed from clinical notes during physiotherapy assessment (Note - there is no set timepoint for this assessment. A decision will be

—

Countries

England, Northern Ireland, United Kingdom, Wales

Contacts

Public ContactHAMLET Trial Team

ytu-hamlet-trial@york.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026