Allogeneic Vascularized Knee Transplantation (kneeTx)
Primary Purpose
Osteitis, Limb Salvage, Joint Deformities, Acquired
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
knee joint transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Osteitis focused on measuring composite tissue allotransplantation, hand transplantation, knee transplantation, face transplantation
Eligibility Criteria
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
Sites / Locations
- Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vascularized transplantation
Arm Description
allogeneic vascularized knee transplantation
Outcomes
Primary Outcome Measures
survival of graft
Clinical examination of graft, x-rays
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01133145
Brief Title
Allogeneic Vascularized Knee Transplantation
Acronym
kneeTx
Official Title
Allogenic Vascularized Knee and Femur Transplantation Clinical Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
High energy trauma often results in severe soft tissue, bone and joint injury. Today, many methods and techniques exist to treat theses severely injured extremities. Surgical techniques include open reduction and internal fixation (ORIF), e.g. with screws and plates, soft tissue reconstruction by local or free flaps and joint reconstruction by arthroplasty, e.g. total knee arthroplasty. In few, very severe cases, those methods are not sufficient to restore function and amputation is the only option left.
In 1908 the German surgeon Erich Lexer had the idea to transplant a joint. Due to the medical situation at his time the attempts failed.
But the idea survived and was processed over the time. Transplant surgery and medicine developed, immunosuppressive drugs were established and animal models proved that bone and joint transplantation is technically feasible.
In 1998 the first successful hand and in 2005 the first partial face transplantation was carried out. In 1996 we started our clinical femur and knee joint transplantation project.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteitis, Limb Salvage, Joint Deformities, Acquired, Skin Transplantation, Bone Transplantation
Keywords
composite tissue allotransplantation, hand transplantation, knee transplantation, face transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vascularized transplantation
Arm Type
Experimental
Arm Description
allogeneic vascularized knee transplantation
Intervention Type
Procedure
Intervention Name(s)
knee joint transplantation
Intervention Description
transplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint
Primary Outcome Measure Information:
Title
survival of graft
Description
Clinical examination of graft, x-rays
Time Frame
2 years after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunther O Hofmann, Prof. Dr.
Organizational Affiliation
Clinic of Trauma-, Hand, and Reconstructive Surgery, University of jena
Official's Role
Study Director
Facility Information:
Facility Name
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
9745561
Citation
Hofmann GO, Kirschner MH, Wagner FD, Brauns L, Gonschorek O, Buhren V. Allogeneic vascularized transplantation of human femoral diaphyses and total knee joints--first clinical experiences. Transplant Proc. 1998 Sep;30(6):2754-61. doi: 10.1016/s0041-1345(98)00803-3.
Results Reference
result
PubMed Identifier
11150987
Citation
Hofmann GO, Kirschner MH. Clinical experience in allogeneic vascularized bone and joint allografting. Microsurgery. 2000;20(8):375-83. doi: 10.1002/1098-2752(2000)20:83.0.co;2-0.
Results Reference
result
PubMed Identifier
10817331
Citation
Kirschner MH, Brauns L, Gonschorek O, Buhren V, Hofmann GO. Vascularised knee joint transplantation in man: the first two years experience. Eur J Surg. 2000 Apr;166(4):320-7. doi: 10.1080/110241500750009186.
Results Reference
result
PubMed Identifier
9665043
Citation
Hofmann GO, Kirschner MH, Brauns L, Wagner FD, Land W, Buhren V. Vascularized knee joint transplantation in man: a report on the first cases. Transpl Int. 1998;11 Suppl 1:S487-90. doi: 10.1007/s001470050525.
Results Reference
result
Links:
URL
http://www.uniklinikum-jena.de
Description
University of Jena, Medicine
Learn more about this trial
Allogeneic Vascularized Knee Transplantation
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