An interventional study of Bilateral allograft of the hands and forearms. and Prosthetic forehands in Bilateral Traumatic Amputation of Upper Limbs, sponsored by Hospices Civils de Lyon. Recruiting at 11 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.
The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.
Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.
The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.
A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's planned enrollment of 40 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Inclusion criteria common to the 2 groups of patients (allograft group and protheses group):
Transplant eligibility criteria (for allograft group)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral allograft of the hands and forearms.
Procedure: Bilateral allograft of the hands and forearms.
Prosthetic forehands
Procedure: Prosthetic forehands
Bilateral allograft of the hands and forearms.
Prosthetic forehands
Treatment cost
Treatment cost of double amputated patients by bilateral allograft of the hands and forearms or by prostheses
Time frame: 36 months
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