Allogeneic Vascularized Knee Transplantation
Ключови думи
Резюме
Описание
Sterile osseous defects of the knee joint are temporarily stabilised with a hinge arthroplasty or an intramedullary nail in the case of a long femoral defect.
Assisted passive motion and isometric exercises are possible and necessary to avoid contractions and muscular atrophy during waiting time. Informed consent has to be obtained.
The knee joint is harvested in accordance with standard organ procurement guidelines used in multi-organ donation (MOD). Authorization for knee donation must be obtained from the donor's families. MODs older than 45 years or those who had an accident involving the same leg are excluded. For additional safety reasons, MODs who had received blood substitutes or fresh-frozen plasma are excluded as well.
Harvesting of the knee joint includes perfusion of the External Iliac Artery with 4 L University of Wisconsin (UW) solution at 4°C, dissection of the femoral artery and vein distally to the proximal level of the adductor canal, transsection of the muscles and osteotomy of the femur, tibia and fibula.
To restore normal appearance of the donor leg a polyethylene spacer is inserted into the bone defect and the skin closed.
The graft then is stored in sterile conditions in three layers of plastic bags at 4° C in UW-solution.
Allograft preparation involves dissection from the surrounding soft tissue with the quadriceps tendon and the articular capsule intact, vessels perfusing the muscles ligated and vessels to the bone preserved.
The graft arterial pedicle is perfused with methylene blue to confirm adequate perfusion for transplantation.
The surgical procedure commences with removal of the spacer or nail. The graft is inserted and fixed by an anterograde femoral and a retrograde tibial interlocking compression nail.
The grafts vessels are anastomosed to the recipient's superficial femoral artery and vein using the end-to-side technique. Reperfusion commences immediately while the ligaments and tendons (Quadriceps Tendon, Iliotibial Tract, Gastrocnemius, Hamstrings) were reconstructed.
Immunosuppression is started immediately after reperfusion of the graft and consists of Antithymocyte Globulin (ATG), 4mg / kg bw i.v. as an induction, FK 506 (Tacrolimus; 10mg p.o.), Mycophenolate Mofetil (MMF; 2g p. o.)and Methylprednisolone, 250mg i.v. for the first 3 days. Oral Double-Drug maintenance therapy is continued with MMF (2g p.o.) and FK 506 (Tacrolimus) with a serum level between 8 and 10 µg/ml from the beginning of the third week.
Дати
Последна проверка: | 04/30/2010 |
Първо изпратено: | 05/26/2010 |
Очаквано записване подадено: | 05/26/2010 |
Първо публикувано: | 05/27/2010 |
Изпратена последна актуализация: | 05/26/2010 |
Последна актуализация публикувана: | 05/27/2010 |
Приблизителна дата на първично завършване: | 11/30/2011 |
Очаквана дата на завършване на проучването: | 05/31/2012 |
Състояние или заболяване
Интервенция / лечение
Procedure: vascularized transplantation
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: vascularized transplantation allogeneic vascularized knee transplantation | Procedure: vascularized transplantation transplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - severly injured knee joint with the combination of: massive bone defect plus articulating cartilage defect plus insufficient extensor mechanism (injury of patella, patella ligament or quadriceps tendon) Exclusion Criteria: - active osteomyelitis - history of malignoma - contraindications for immunosuppressive medication |
Резултат
Първични изходни мерки
1. survival of graft [2 years after transplantation]