Impact of the Excess Weight Loss on Mineralization Patter... | NCT02404090

Studies
Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations

NCT02404090

Sponsor

Marko Kraljevic

Status

Unknown status

Last Update Posted

Mar 31, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Obesity
Weight Loss
Knee Osteoarthritis

Interventions

CT-osteoarbsorptiometry

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Mar 26, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Mar 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-osteoarbsorptiometry	Radiation	Conventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mineralization changes after excess weight loss?		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Bariatric patients with BMI > 35 kg/m2 with knee pain (VAS > 2).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marko Kraljevic, MD	Contact			marko.kraljevic@gmail.com

Overall Officials

Name	Affiliation	Role
Urs Zingg, MD	Spital Limmattal Schlieren	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided