Revision of Meniscal TransplantNCT01189357
Revision Meniscal Transplants; Lateral and Medial
An observational study of Revision of Meniscal Transplant, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision of Meniscal Transplant
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Jul 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: failed meniscal transplantation
Who may be able to join
- failed Meniscal transplantation between 1989 and 1999
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Revision of Meniscal Transplant
- Keywords
- meniscal transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| failed meniscal transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years after surgery
Secondary outcomes (1)
Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant.
Measured: 20 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision of Meniscal TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- René Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189357
- Sponsor's protocol ID
- 2010/358
- Status last verified
- Jul 2011
- First submitted
- 25 Aug 2010
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revision Meniscal Transplants; Lateral and Medial
- ClinicalTrials.gov ID
- NCT01189357
- Acronym / sponsor ID
- 2010/358
- Conditions
- Revision of Meniscal Transplant
- Keywords
- meniscal transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| failed meniscal transplantation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- failed meniscal transplantation
Key inclusion criteria (1 listed)
- failed Meniscal transplantation between 1989 and 1999
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis.
Time frame: 20 years after surgery
The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36) and clinical examination.
1 secondary outcome
Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant.
Time frame: 20 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- website University Hospital GhentLink provided by the sponsor.
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.
René Verdonk, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision of Meniscal Transplant, run by University Hospital, Ghent at 1 site in Belgium.
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 0 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: finished, as of the sponsor's last update on 14 Jul 2011. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis. (time frame: 20 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2011; AzTrials last refreshed its copy on 3 Nov 2026.