NCT03460691

Brief Summary

Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

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 Mar 2018

Shorter than P25 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 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 2, 2018

Last Update Submit

March 8, 2018

Conditions

Bariatric SurgeryCentral Sensitization

Keywords

bariatric surgerycentral sensitizationknee painfunctionquality of life

Outcome Measures

Primary Outcomes (4)

  • numeric rating scale (NRS)

    It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).

    6 months

  • Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    for function

    6 months

  • Nottingham Health Profile

    for quality of life

    6 months

  • Central Sensitization Inventory (CSI)

    for central sensitization

    6 months

Study Arms (1)

Group 1

Group 1:patients who will undergo the bariatric surgery

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Bariatric surgery will done to the patients who were morbid obesity

Group 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are morbid obesity and had decided to undergo bariatric surgery

You may qualify if:

  • Patients decided to undergo bariatric surgery
  • Patients with knee pain more than 3 months.

You may not qualify if:

  • Patients with mental impairment,
  • Patients with inflammatory rheumatic disease,
  • Patients who had previously undergone knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Burcu Metin Ökmen

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Metin Ökmen, M.D.

CONTACT

+902242955000burcumetinokmen@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 9, 2018

Study Start

March 9, 2018

Primary Completion

December 9, 2018

Study Completion

December 9, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03