Assessment of Knee Arthrosis After Bariatric Surgery

Completed

• Conditions: Bariatric Surgery Candidate
• Interventions: Other: knee MRI

• Registration Number: NCT01207024
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2013-04
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• bariatric surgery
• IMC >= 35

Exclusion Criteria

• those of bariatric surgery
• contra-indication to MRI
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
knee MRI	knee MRI	knee MRI for all patients undergoing bariatric surgery as usual care

Primary Outcome Measures

Name	Time	Method
variation of knee joint space thickness	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	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.

Secondary Outcome Measures

Name	Time	Method
mean pain and disability	24 hours	mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.
evolution of KOOS score after surgery	6 months, 1 year and two years	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	6 months, 1 year, 2 years	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.
prevalence of atherosis	24 hours	Pain Scores on the Visual Analog Scale \>= 3 and/or radiological signs of atherosis
evolution of the proportion of patients in pain	6 months, 1 year and two years	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	6 months, 1 year and two years	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.

Trial Locations

Locations (1)

Louis Mourier hospital (AP-HP); 🇫🇷 Colombes, France