Overview

This trial is active, not recruiting.

Condition bariatric surgery candidate
Treatment knee mri
Phase phase 4
Sponsor Assistance Publique - Hôpitaux de Paris
Start date February 2009
End date April 2013
Trial size 80 participants
Trial identifier NCT01207024, P071225

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
knee MRI for all patients undergoing bariatric surgery as usual care
knee mri knee MRI
knee MRI before surgery (inclusion) and one year after

Primary Outcomes

Measure
variation of knee joint space thickness
time frame: 24 hours, one year
proportion of patients with pain
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

Inclusion Criteria: - bariatric surgery - IMC >= 35 Exclusion Criteria: - those of bariatric surgery - contra-indication to MRI - pregnancy

Additional Information

Official title Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
Principal investigator Elisabeth Dion, MD, Phd
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.