Bariatric Surgery CandidateBASIKNCT01207024
Assessment of Knee Arthrosis After Bariatric Surgery
An observational study of Bariatric Surgery Candidate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- knee MRI
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Sep 2014
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Inclusion Criteria: * bariatric surgery * IMC >= 35 Exclusion Criteria: * those of bariatric surgery * contra-indication to MRI * pregnancy
Who may be able to join
- bariatric surgery
- IMC >= 35
Who cannot join
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
Knee MRI is not currently part of the investigations preceding bariatric surgery.
Read the detailed description
Assessment of knee arthrosis in severely obese patients after bariatric surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- knee MRI
- Keywords
- knee arthrosis, obesity, MRI, bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee MRIOther
knee MRI before surgery (inclusion) and one year after
| Study group | Role | What they receive |
|---|---|---|
| knee MRI | knee MRI for all patients undergoing bariatric surgery as usual care Receives: Other: knee MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of knee joint space thickness
Joint space variation in percentages (mean joint space variation calculated for each patient group). Mean joint space comparison between 2 groups of obese patients: patients with Bypass surgery versus patients without surgery.
Measured: 24 hours, one year
proportion of patients with pain
proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 (for at least one knee). Comparison at one year after bariatric surgery versus inclusion.
Measured: 1 year
Secondary outcomes (6)
prevalence of atherosis
Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis
Measured: 24 hours
mean pain and disability
mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.
Measured: 24 hours
evolution of KOOS score after surgery
Among the 80 patients undergoing surgery, comparison of KOOS function score before surgery versus 6 months, 1 year and two years after surgery.
Measured: 6 months, 1 year and two years
evolution of pain scores after surgery
Among the 80 patients undergoing surgery, comparison of mean Pain Scores on the Visual Analog Scale before surgery versus 6 months, 1 year and two years after surgery.
Measured: 6 months, 1 year, 2 years
evolution of the proportion of patients in pain
Among the 80 patients undergoing surgery, comparison of the proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 before surgery versus 6 months, 1 year and two years after surgery.
Measured: 6 months, 1 year and two years
evolution of knee MRI parameters after surgery
Among the 80 patients undergoing surgery, comparison of the MRI parameters (T2, cartilage volume, œdema of sub-chondral spongious bone) before surgery versus 6 months, 1 year and two years after surgery.
Measured: 6 months, 1 year and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startFeb 2009
- Primary completionApr 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Dion, MD, Phd, Principal investigator, Louis Mourier University Hospital (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207024
- Sponsor's protocol ID
- P071225
- Acronym
- BASIK
- Status last verified
- Dec 2014
- First submitted
- 26 Aug 2010
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT01207024
- Acronym / sponsor ID
- BASIK / P071225
- Conditions
- Bariatric Surgery Candidate
- Keywords
- knee arthrosis, obesity, MRI, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Sep 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.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
Knee MRI is not currently part of the investigations preceding bariatric surgery.
Detailed description
Assessment of knee arthrosis in severely obese patients after bariatric surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee MRI | – | Other: knee MRIknee MRI for all patients undergoing bariatric surgery as usual care |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Inclusion Criteria: * bariatric surgery * IMC >= 35 Exclusion Criteria: * those of bariatric surgery * contra-indication to MRI * pregnancy
Key inclusion criteria (2 listed)
- bariatric surgery
- IMC >= 35
Key exclusion criteria (3 listed)
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
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 |
|---|---|---|
| knee MRIknee MRI before surgery (inclusion) and one year after | Other | knee MRI |
Primary outcome
variation of knee joint space thickness
Time frame: 24 hours, one year
Joint space variation in percentages (mean joint space variation calculated for each patient group). Mean joint space comparison between 2 groups of obese patients: patients with Bypass surgery versus patients without surgery.
proportion of patients with pain
Time frame: 1 year
proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 (for at least one knee). Comparison at one year after bariatric surgery versus inclusion.
6 secondary outcomes
prevalence of atherosis
Time frame: 24 hours
mean pain and disability
Time frame: 24 hours
evolution of KOOS score after surgery
Time frame: 6 months, 1 year and two years
evolution of pain scores after surgery
Time frame: 6 months, 1 year, 2 years
evolution of the proportion of patients in pain
Time frame: 6 months, 1 year and two years
evolution of knee MRI parameters after surgery
Time frame: 6 months, 1 year and two years
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 23 Dec 2014.
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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.
Elisabeth Dion, MD, Phd principal investigator
Louis Mourier University Hospital (AP-HP)
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 Bariatric Surgery Candidate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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 23 Dec 2014. 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 France. 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?
variation of knee joint space thickness (time frame: 24 hours, one year). The study lists 2 primary outcomes in all. 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 23 Dec 2014.