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Completed

NCT Number: NCT01207024

Assessment of Knee Arthrosis 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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Louis Mourier hospital (AP-HP)

Colombes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • bariatric surgery
  • IMC >= 35

Exclusion criteria

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

Treatment and study plan

knee MRI

Other

knee MRI before surgery (inclusion) and one year after

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. prevalence of atherosis

    Time frame: 24 hours

    Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: BASIK

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Sep 22, 2010
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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