Multimodal Assessment of Knee Conditions | NCT02937064

Studies
Multimodal Assessment of Knee Conditions

NCT02937064

Sponsor

University of Oulu

Status

Completed

Last Update Posted

May 4, 2017Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Osteoarthritis
Injury of Anterior Cruciate Ligament
Knee Injuries and Disorders

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2017

Last Update Posted Date

May 4, 2017Actual

Name	Class
Oulu University Hospital	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging)		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 45 - 65

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simo Saarakkala, Ph.D.	University of Oulu	Principal Investigator
Osmo Tervonen, M.D., Ph.D.	Oulu University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univerisity of Oulu		Oulu		90014	Finland

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D000070598	Anterior Cruciate Ligament Injuries
D007718	Knee Injuries
D004194	Disease

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided