Meniscal TearNCT04647942
Is Meniscal Volume Critical to Post-meniscectomy Symptoms?
An observational study of Meniscal Tear, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Meniscal Tear
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Feb 2016
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's. * Age between 14 and 60 years old * Women of child bearing age can be included: the study has no effect on their methods of contraception.
Who may be able to join
- All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
- Age between 14 and 60 years old
- Women of child bearing age can be included: the study has no effect on their methods of contraception.
Who cannot join
- A history of a tibia plateau fracture or severe deformity of the knee
- Rupture of the ACL/PCL/collateral ligaments of the knee
- Focal cartilage defects of the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study
With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.
Read the detailed description
- Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain.
- Trial objectives and Design 2.1 Trial objectives With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain. 2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain. 2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain.
- Selection and withdrawal of subjects
3.1 Inclusion criteria
- All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
- Age between 14 and 50 years old
- Women of child bearing age can be included: the study has no effect on their methods of contraception.
3.2 Exclusion criteria
- A history of a tibia plateau fracture or severe deformity of the knee
- Rupture of the ACL/PCL/collateral ligaments of the knee
- Focal cartilage defects of the knee
- Conditions
- Meniscal Tear
- Keywords
- meniscectomy, volume, pain
- Medical subject headings
- Pain
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 |
|---|---|---|
| Meniscectomy | Patients who underwent a meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
How much volume can be resected peroperatively without developing postoperative pain.
A possible correlation between the resected volume and the severity of the pain.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study startDec 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Bellemans, MD, PhD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647942
- Sponsor's protocol ID
- V1 07112013
- Status last verified
- Nov 2020
- First submitted
- 22 Dec 2013
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study
- ClinicalTrials.gov ID
- NCT04647942
- Acronym / sponsor ID
- V1 07112013
- Conditions
- Meniscal Tear
- Keywords
- meniscectomy, volume, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Dec 2020 (actual)
- 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.
With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.
Detailed description
- Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain.
- Trial objectives and Design 2.1 Trial objectives With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain. 2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain. 2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain.
- Selection and withdrawal of subjects
3.1 Inclusion criteria
- All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
- Age between 14 and 50 years old
- Women of child bearing age can be included: the study has no effect on their methods of contraception.
3.2 Exclusion criteria
- A history of a tibia plateau fracture or severe deformity of the knee
- Rupture of the ACL/PCL/collateral ligaments of the knee
- Focal cartilage defects of the knee
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meniscectomy | – | –Patients who underwent a meniscectomy |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's. * Age between 14 and 60 years old * Women of child bearing age can be included: the study has no effect on their methods of contraception.
Key inclusion criteria (3 listed)
- All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
- Age between 14 and 60 years old
- Women of child bearing age can be included: the study has no effect on their methods of contraception.
Key exclusion criteria (3 listed)
- A history of a tibia plateau fracture or severe deformity of the knee
- Rupture of the ACL/PCL/collateral ligaments of the knee
- Focal cartilage defects of the knee
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
How much volume can be resected peroperatively without developing postoperative pain.
Time frame: 3 years
A possible correlation between the resected volume and the severity of the pain.
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 1 Dec 2020.
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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.
Johan Bellemans, MD, PhD study director
UZ Leuven
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 Meniscal Tear, run by Universitaire Ziekenhuizen KU Leuven 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 3 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: finished, as of the sponsor's last update on 1 Dec 2020. 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?
How much volume can be resected peroperatively without developing postoperative pain. (time frame: 3 years). 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 1 Dec 2020.