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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02404090
Other study ID # SLS-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 26, 2015
Last updated March 26, 2015
Start date August 2015
Est. completion date August 2021

Study information

Verified date March 2015
Source Spital Limmattal Schlieren
Contact Marko Kraljevic, MD
Email marko.kraljevic@gmail.com
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI > 35

- need for bariatric operation

- knee pain (VAS > 2)

Exclusion Criteria:

- malignancy

- poor compliance

- previous bariatric operation

- pregnancy

- lack of knee pain (VAC < 2)

- previous knee operation

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Radiation:
CT-osteoarbsorptiometry
Conventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Marko Kraljevic

Outcome

Type Measure Description Time frame Safety issue
Primary Mineralization changes after excess weight loss? 5 years No
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