Assessment of Knee Arthrosis After Bariatric Surgery (BASIK)

December 19, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France
        • Louis Mourier Hospital (AP-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria:

  • bariatric surgery
  • IMC >= 35

Exclusion Criteria:

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

Description

Inclusion Criteria:

  • bariatric surgery
  • IMC >= 35

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours, one year
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Elisabeth Dion, MD, Phd, Louis Mourier University Hospital (AP-HP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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