Assessment of Knee Arthrosis After Bariatric Surgery

NCT01207024 | Completed

• 1 other identifier: P071225
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

knee arthrosis; obesity; MRI; bariatric surgery

Outcome Measures

Primary Outcomes (2)

• variation of knee joint space thickness

  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

  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 Outcomes (6)

• prevalence of atherosis

  24 hours

• mean pain and disability

  24 hours

• evolution of KOOS score after surgery

  6 months, 1 year and two years

• evolution of pain scores after surgery

  6 months, 1 year, 2 years

• evolution of the proportion of patients in pain

  6 months, 1 year and two years

Study Arms (1)

knee MRI

knee MRI for all patients undergoing bariatric surgery as usual care

Other: knee MRI

Interventions

knee MRI OTHER

knee MRI before surgery (inclusion) and one year after

knee MRI

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• bariatric surgery
• IMC \>= 35

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Louis Mourier hospital (AP-HP)

Colombes, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth Dion, MD, Phd

  Louis Mourier University Hospital (AP-HP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 22, 2010
• Study Start: February 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

FR (1)