NCT02937064

Brief Summary

The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

October 12, 2016

Last Update Submit

May 3, 2017

Conditions

OsteoarthritisInjury of Anterior Cruciate LigamentKnee Injuries and Disorders

Outcome Measures

Primary Outcomes (1)

  • Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging)

    6 months

Study Arms (6)

Controls

Controls

ACL subjects

Subjects with anterior cruciate ligament injuries.

OA1, doubtful OA

Subjects with doubtful osteoarthritis.

OA2, mild OA

Subjects with mild osteoarthritis.

OA3, moderate OA

Subjects with moderate osteoarthritis.

OA4, severe OA

Subjects with severe osteoarthritis.

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Controls will be recruited using the newspaper advertisement. Subject with anterior cruciate ligament injuries will be recruited from the orthopaedic department and osteoarthritic subjects using patient Records of Oulu University Hospital.

You may qualify if:

  • Age 45 - 65

You may not qualify if:

  • Rheumatoid arthritis
  • Weight over 110 kg
  • Previous total knee replacement surgery
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Oulu

Oulu, 90014, Finland

Location

MeSH Terms

Conditions

OsteoarthritisAnterior Cruciate Ligament InjuriesKnee InjuriesDisease

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simo Saarakkala, Ph.D.

    University of Oulu

    PRINCIPAL INVESTIGATOR

  • Osmo Tervonen, M.D., Ph.D.

    Oulu University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

FI(1)