Assessment of Knee Arthrosis After Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— BASIK  

Official title:

Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207024
• Other study ID #: P071225
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: December 19, 2014
• Start date: February 2009
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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.

Knee MRI is not currently part of the investigations preceding bariatric surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• bariatric surgery

• IMC >= 35

Exclusion Criteria:

• those of bariatric surgery

• contra-indication to MRI

• pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Other:
• knee MRI
knee MRI before surgery (inclusion) and one year after

Locations

Country	Name	City	State
France	Louis Mourier hospital (AP-HP)	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours, one year	No
Primary	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.	1 year	No
Secondary	prevalence of atherosis	Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis	24 hours	No
Secondary	mean pain and disability	mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.	24 hours	No
Secondary	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.	6 months, 1 year and two years	No
Secondary	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.	6 months, 1 year, 2 years	No
Secondary	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.	6 months, 1 year and two years	No
Secondary	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.	6 months, 1 year and two years	No