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NCT01382173 Clinical Trial

Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)

Knee Osteoarthritis Clinical Trial

Official title:
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01382173
Other study ID # MOHAK-11
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2012
Est. completion date September 2020

Study information
Verified date September 2020
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.

Recruitment information / eligibility
Status Terminated
Enrollment 192
Est. completion date September 2020
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years to 40 Years
Eligibility Inclusion Criteria:

1. Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)

2. A history of knee injury not more than 4 weeks prior to inclusion

3. Agreement and informed consent to participate in the study

Exclusion Criteria:

1. Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)

2. Pregnancy

3. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system

4. General disease that effects physical function or systemic medication/abuse of steroids

5. Any other condition or treatment interfering with the completion or assessment of the trial.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Department of Orthopedics, Helsingborg hospital Helsingborg

Sponsors (3)
Lead Sponsor Collaborator
Lund University Crafoord Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee injury and Osteoarthritis Outcome Score (KOOS) 5 yrs
Secondary Radiographic osteoarthritis 5 yrs
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