NCT01133145

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 28, 2010

Status Verified

May 1, 2010

First QC Date

May 27, 2010

Last Update Submit

May 27, 2010

Conditions

OsteitisLimb SalvageJoint Deformities, AcquiredSkin TransplantationBone Transplantation

Keywords

composite tissue allotransplantationhand transplantationknee transplantationface transplantation

Outcome Measures

Primary Outcomes (1)

  • survival of graft

    Clinical examination of graft, x-rays

    2 years after transplantation

Study Arms (1)

vascularized transplantation

EXPERIMENTAL

allogeneic vascularized knee transplantation

Procedure: knee joint transplantation

Interventions

knee joint transplantationPROCEDURE

transplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint

vascularized transplantation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • active osteomyelitis
  • history of malignoma
  • contraindications for immunosuppressive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena

Jena, 07747, Germany

Location

Related Publications (4)

  • 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.

    PMID: 9745561RESULT

  • 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.

    PMID: 11150987RESULT

  • 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.

    PMID: 10817331RESULT

  • 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.

    PMID: 9665043RESULT

Related Links

MeSH Terms

Conditions

OsteitisJoint Deformities, Acquired

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesJoint Diseases

Study Officials

  • Gunther O Hofmann, Prof. Dr.

    Clinic of Trauma-, Hand, and Reconstructive Surgery, University of jena

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

May 28, 2010

Record last verified: 2010-05

Locations

DE(1)