OsteitiskneeTxNCT01133145
Allogeneic Vascularized Knee Transplantation
A study testing knee joint transplantation in people with Osteitis and Limb Salvage, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Osteitis, Limb Salvage, Joint Deformities, Acquired
- What is being tested?
- knee joint transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- active osteomyelitis
- history of malignoma
- contraindications for immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena
Jena, 07747
About this study
Official title: Allogenic Vascularized Knee and Femur Transplantation Clinical Evaluation
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.
Read more
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.
Read the 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.
- Conditions
- Osteitis, Limb Salvage, Joint Deformities, Acquired, Skin Transplantation, Bone Transplantation
- Being tested
- knee joint transplantation
- Keywords
- composite tissue allotransplantation, hand transplantation, knee transplantation, face transplantation
- Medical subject headings
- Osteitis, Joint Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee joint transplantationProcedure or surgery
transplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint
| Study group | Role | What they receive |
|---|---|---|
| vascularized transplantation | Experimental | allogeneic vascularized knee transplantation Receives: Procedure: knee joint transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival of graft
Clinical examination of graft, x-rays
Measured: 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Gunther O Hofmann, Prof. Dr., Study director, Clinic of Trauma-, Hand, and Reconstructive Surgery, University of jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133145
- Sponsor's protocol ID
- knee Tx
- Acronym
- kneeTx
- Status last verified
- May 2010
- First submitted
- 27 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9745561Hofmann 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.
PubMed 11150987Kirschner 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.
PubMed 10817331Hofmann 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.
PubMed 9665043
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Vascularized Knee and Femur Transplantation Clinical Evaluation
- ClinicalTrials.gov ID
- NCT01133145
- Acronym / sponsor ID
- kneeTx / knee Tx
- Conditions
- Osteitis, Limb Salvage, Joint Deformities, Acquired, Skin Transplantation, Bone Transplantation
- Keywords
- composite tissue allotransplantation, hand transplantation, knee transplantation, face transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascularized transplantation | Experimental | Procedure: knee joint transplantationallogeneic vascularized knee transplantation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- active osteomyelitis
- history of malignoma
- contraindications for immunosuppressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knee joint transplantationtransplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint | Procedure or surgery | vascularized transplantation |
Primary outcome
survival of graft
Time frame: 2 years after transplantation
Clinical examination of graft, x-rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Results publication: PubMed 9745561Hofmann 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 publication: PubMed 11150987Hofmann 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 publication: PubMed 10817331Kirschner 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 publication: PubMed 9665043Hofmann 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.
- University of Jena, MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunther O Hofmann, Prof. Dr. study director
Clinic of Trauma-, Hand, and Reconstructive Surgery, University of jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee joint transplantation in people with Osteitis and Limb Salvage, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival of graft (time frame: 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01133145, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.