NCT00820430

Brief Summary

The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

5 active sites

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

November 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

January 9, 2009

Last Update Submit

July 18, 2023

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritiskneemagnetic resonance imagingknee cartilagereproducibility

Outcome Measures

Primary Outcomes (1)

  • The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions.

    4 sequental MRI evaluations of the target knee within a 4-week period

Study Arms (3)

Control--Non-Osteoporotic Knee

Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years

Other: Magnetic Resonance Imaging

Minimal Osteoarthritis, Knee

Kellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit

Other: Magnetic Resonance Imaging

Moderate Osteoarthritis, Knee

Kellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit

Other: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingOTHER

Subjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho).

Also known as: MRI, knee MRI, knee magnetic resonance imaging
Control--Non-Osteoporotic KneeMinimal Osteoarthritis, KneeModerate Osteoarthritis, Knee

Eligibility Criteria

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

This multi-center trial comprises only facilities within Pennsylvania. Study participants for the normal cohorts will be recruited through print flyers. It is anticipated that the study participants with mild to moderate OA will be identified by the radiologists interpreting the knee x-rays.

You may qualify if:

  • Participants must be \>18 years old;
  • Participants must have a KL score between 0 and 3;
  • Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
  • Participant had no change of treatment occur within the last 6 months;
  • Participants have no plans of changing to a different treatment within the next 3 months;
  • Participant must provide a study-specific signed informed consent form.

You may not qualify if:

  • Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
  • Patients with prior knee surgery or trauma of the knee;
  • Patients with KL score of 4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19017, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Timothy J Mosher, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Ravinder Reddy, PhD

    University of Pennsylvania, MMRRCC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

November 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

US(5)