Assessing Outcomes After Treatment for Severe Hand or Arm Injury v1

• Research type

  Research Study

• Full title

  Assessing the Benefits of Hand Transplant Compared with Other Treatments

• IRAS ID

  327315

• Contact name

  David Alan Leonard

• Contact email

  david.leonard6@nhs.net

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Clinicaltrials.gov Identifier

  University of Delaware Funding Reference, W81XWH-20-2-0062

• Duration of Study in the UK

  3 years, 0 months, 31 days

• Research summary

  The purpose of this study is to document the objective psychosocial and quality-of-life outcomes of hand transplant compared to other treatment options and evaluate these outcomes over time.

  Background
  The loss of a limb—particularly a hand or arm amputation—is devastating and disabling. In addition to loss of physical functioning and independence, these injuries can significantly affect a person’s emotional well-being, social interactions, and overall quality of life. Hand transplantation can restore physical functions—including sensation and physical ability to use one’s hand(s) independently—and qualitative evidence from our team’s research suggests that hand transplantation can also improve well-being and quality of life. However, there are risks to receiving hand transplant surgery, including the need for lifelong immunosuppression that can lead to other health problems, such as cancer or organ damage. It is difficult, therefore, for patients and doctors to weigh the risks and benefits of undergoing hand transplantation.

  Potential Benefits
  The knowledge gained from this study may contribute to our understanding of the relative value and impact of hand transplantation.

  Study Design
  We will conduct qualitative interviews with participants from four different clinical groups: (1) individuals who have undergone hand transplantation, (2) individuals with severe upper-extremity injuries who have undergone limb reconstruction surgery, (3) individuals with upper-extremity amputation who use prosthetic devices, and (4) individuals with upper-extremity amputation who use osseointegrated prosthetic devices. Participants will be interviewed using open-ended questions and patient-reported outcome items to understand their experiences of the benefits, value, and downsides of the treatment they have received. Interviews will last approximately 2 hours. Participants will be interviewed again after 1 year, to evaluate any changes they may have experienced over time.

  Funding
  United States (US) Department of Defense Reconstructive Transplant Research Program

  Participating Institutions
  Nine sites in the US and UK including those with active hand transplant programs and/or with populations of individuals with upper extremity injury or loss

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  25/WM/0151

• Date of REC Opinion

  19 Dec 2025

• REC opinion

  Further Information Favourable Opinion