Assessment of Knee Arthrosis After Bariatric Surgery (BASIK)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01207024
First received: August 26, 2010
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Bariatric Surgery Candidate
Other: knee MRI
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • variation of knee joint space thickness [ Time Frame: 24 hours, one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • prevalence of atherosis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis

  • mean pain and disability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.

  • evolution of KOOS score after surgery [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    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.

  • evolution of the proportion of patients in pain [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months, 1 year and two years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: February 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: knee MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • bariatric surgery
  • IMC >= 35

Exclusion Criteria:

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

Inclusion Criteria:

  • bariatric surgery
  • IMC >= 35

Exclusion Criteria:

  • those of bariatric surgery
  • contra-indication to MRI
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207024

Locations
France
Louis Mourier hospital (AP-HP)
Colombes, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Elisabeth Dion, MD, Phd Louis Mourier University Hospital (AP-HP)
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01207024     History of Changes
Other Study ID Numbers: P071225
Study First Received: August 26, 2010
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
knee arthrosis
obesity
MRI
bariatric surgery

ClinicalTrials.gov processed this record on September 30, 2014