NCT02404090

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

March 26, 2015

Last Update Submit

March 26, 2015

Conditions

ObesityWeight LossKnee Osteoarthritis

Keywords

ObesityWeight LossKnee OsteoarthritisSubchondral Mineralization

Outcome Measures

Primary Outcomes (1)

  • Mineralization changes after excess weight loss?

    5 years

Interventions

CT-osteoarbsorptiometryRADIATION

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • BMI \> 35
  • need for bariatric operation
  • knee pain (VAS \> 2)

You may not qualify if:

  • malignancy
  • poor compliance
  • previous bariatric operation
  • pregnancy
  • lack of knee pain (VAC \< 2)
  • previous knee operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight LossOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Urs Zingg, MD

    Spital Limmattal Schlieren

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marko Kraljevic, MD

CONTACT

marko.kraljevic@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2020

Study Completion

August 1, 2021

Last Updated

March 31, 2015

Record last verified: 2015-03