Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01382173
Recruitment Status : Recruiting
First Posted : June 27, 2011
Last Update Posted : September 11, 2015
The Swedish Research Council
Crafoord Foundation
Information provided by (Responsible Party):
Richard B Frobell, Lund University

Brief 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.

Condition or disease
Knee Injury Knee Osteoarthritis

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Acute Knee Injury Project
Study Start Date : March 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 yrs ]

Secondary Outcome Measures :
  1. Radiographic osteoarthritis [ Time Frame: 5 yrs ]

Biospecimen Retention:   Samples Without DNA
Joint fluid, Serum & Plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We will recruit approximately 150 patients annually over 3-4 years with the goal of including at least:

  • 200 knees with isolated or combined ACL injuries
  • 50 isolated meniscus tears
  • 50 primary patellar dislocations
  • 50 contusions without ligamentous, cartilage or meniscus injury.

Patients will be recruited using two different strategies:

  1. Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital
  2. Those referred to the orthopedic outpatient health care unit of Helsingborg hospital due to an acute knee injury by their primary health care unit will be scheduled for a clinical visit for baseline assessment (visit 1) within four weeks from their injury. To facilitate recruitment, primary care units in the local area of Helsingborg will be offered an opportunity to refer all patients with rotational knee trauma and effusion directly to the orthopedic outpatient care unit.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382173

Contact: Richard B Frobell, PhD +46424061027
Contact: Ola A Olsson, MD, PhD +46424063535

Department of Orthopedics, Helsingborg hospital Recruiting
Helsingborg, Sweden, S-251 85
Contact: Kerstin Akesson    +46424062032   
Principal Investigator: Richard B Frobell, PhD         
Sponsors and Collaborators
Lund University
The Swedish Research Council
Crafoord Foundation

Responsible Party: Richard B Frobell, Associate Professor, Lund University Identifier: NCT01382173     History of Changes
Other Study ID Numbers: MOHAK-11
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Richard B Frobell, Lund University:
Knee injury
Anterior Cruciate Ligament injury
Patellar dislocation

Additional relevant MeSH terms:
Wounds and Injuries
Osteoarthritis, Knee
Knee Injuries
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries