Assessment of Knee Arthrosis After Bariatric Surgery (BASIK)
This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01207024
First received: August 26, 2010
Last updated: August 4, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bariatric Surgery Candidate |
Other: knee MRI |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery. |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- variation of knee joint space thickness [ Time Frame: 24 hours, one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- prevalence of atherosis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis
- mean pain and disability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.
- evolution of KOOS score after surgery [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]Among the 80 patients undergoing surgery, comparison of KOOS function score before surgery versus 6 months, 1 year and two years after surgery.
- evolution of pain scores after surgery [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]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.
- evolution of the proportion of patients in pain [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]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.
- evolution of knee MRI parameters after surgery [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
knee MRI
knee MRI for all patients undergoing bariatric surgery as usual care
|
Other: knee MRI
knee MRI before surgery (inclusion) and one year after
Other Name: knee MRI
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
Criteria
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207024
Contacts
| Contact: Laurence SALOMON, MD, PhD | +33(0) 1 47 60 67 27 | laurence.salomon@lmr.aphp.fr |
Locations
| France | |
| Louis Mourier hospital (AP-HP) | Recruiting |
| Colombes, France | |
| Contact: Laurence SALOMON, MD, PhD +33(0) 1 47 60 67 27 laurence.salomon@lmr.aphp.fr | |
| Principal Investigator: Elisabeth Dion, Md, phd | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Elisabeth Dion, MD, Phd | Louis Mourier University Hospital (AP-HP) |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01207024 History of Changes |
| Other Study ID Numbers: | P071225 |
| Study First Received: | August 26, 2010 |
| Last Updated: | August 4, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
knee arthrosis obesity MRI bariatric surgery |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Musculoskeletal Diseases Arthritis Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013