Revision of Meniscal Transplant Clinical Trial
Official title:
Revision Meniscal Transplants; Lateral and Medial
| Verified date | July 2011 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Observational |
During the period 1989-1999, a number of patients underwent a meniscal transplantation. A
few transplants were not successful. These patients form the population of this study. They
all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after
the failure of the transplants The goal of this study is to evaluate their current medical
condition, to perform a survival analysis, and to determine the clinical outcome.
The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS
and SF-36)and clinical examination.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - failed Meniscal transplantation between 1989 and 1999 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis. | The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36) and clinical examination. | 20 years after surgery | No |
| Secondary | Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant. | 20 years after surgery | No |