MeniscectomyNCT01158677
Short Term Outcome After Meniscectomy
An observational study of Meniscectomy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscectomy
- What is being tested?
- Meniscectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2010to Jul 2015
- 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: all the meniscectomy patients (male \& female, all ages)
Who may be able to join
- all the meniscectomy patients (male \& female, all ages)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery.
This prospective study examens the clinical outcome after meniscectomy using questionnaires (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 \& 12 months postoperative.) The investigators will also record the further treatment options for the people at risk.
- Conditions
- Meniscectomy
- Being tested
- Meniscectomy
- Keywords
- meniscectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeniscectomyProcedure or surgery
patients undergoing meniscectomy will be asked to complete the KOOS-scale,Vas-scale, Tegner questionnaire, SF-36 questionnaire pre-operatively and at 3, 6 and 12 months post-operatively
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical outcome (residual lesions) after a meniscectomy
KOOS-scale, Vas-scale, Tegner questionnaire, SF-36 questionnaire
Measured: 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeniscectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Verdonk, MD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158677
- Sponsor's protocol ID
- 2010/117
- Status last verified
- Dec 2022
- First submitted
- 7 Jul 2010
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome After Meniscectomy
- ClinicalTrials.gov ID
- NCT01158677
- Acronym / sponsor ID
- 2010/117
- Conditions
- Meniscectomy
- Keywords
- meniscectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Jul 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.
Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery.
This prospective study examens the clinical outcome after meniscectomy using questionnaires (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 \& 12 months postoperative.) The investigators will also record the further treatment options for the people at risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all the meniscectomy patients (male \& female, all ages)
Key inclusion criteria (1 listed)
- all the meniscectomy patients (male \& female, all ages)
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meniscectomypatients undergoing meniscectomy will be asked to complete the KOOS-scale,Vas-scale, Tegner questionnaire, SF-36 questionnaire pre-operatively and at 3, 6 and 12 months post-operatively | Procedure or surgery | – |
Primary outcome
The clinical outcome (residual lesions) after a meniscectomy
Time frame: 12 months post-operative
KOOS-scale, Vas-scale, Tegner questionnaire, SF-36 questionnaire
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 Dec 2022.
- website of University Hospital Ghent, BelgiumLink 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.
Peter Verdonk, MD principal investigator
University Hospital Ghent, Belgium
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 Meniscectomy, 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 Dec 2022. 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?
The clinical outcome (residual lesions) after a meniscectomy (time frame: 12 months post-operative). 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 Dec 2022.