NCT01359553

Brief Summary

The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

May 22, 2011

Last Update Submit

October 24, 2016

Conditions

Knee OsteoarthritisKnee Injuries

Outcome Measures

Primary Outcomes (1)

  • Arthroscopical OA grade

    2014

Study Arms (1)

Knee pain

Group with knee pain problems referred to an arthroscopy.

Other: Intra-articular ultrasound imaging of knee joint during arthroscopyOther: Non-invasive ultrasound imaging of kneeOther: Quantitative MRI imaging of kneeOther: Contrast-enhanced CT imaging of knee

Interventions

Intra-articular ultrasound imaging of knee joint during arthroscopyOTHER
Knee pain
Non-invasive ultrasound imaging of kneeOTHER
Knee pain
Quantitative MRI imaging of kneeOTHER
Knee pain
Contrast-enhanced CT imaging of kneeOTHER
Knee pain

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected from those referred to an arthroscopy because of pain symptoms in the knee.

You may qualify if:

  • Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI
  • Age \>= 20 years

You may not qualify if:

  • Tumor or inflammation in the knee
  • Severe general diseases
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, FI-90029, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Study Officials

  • Simo Saarakkala, Ph.D.

    University of Oulu and Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Petri Lehenkari, M.D., Ph.D.

    University of Oulu and Oulu University Hospital

    STUDY DIRECTOR

  • Miika T Nieminen, Ph.D.

    University of Oulu and Oulu University Hospital

    STUDY DIRECTOR

  • Risto Ojala, M.D., Ph.D.

    Oulu University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2011

First Posted

May 24, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

FI(1)