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

June 23, 2011
June 27, 2011
September 11, 2015
March 2012
January 2017   (Final data collection date for primary outcome measure)
Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 yrs ]
Same as current
Complete list of historical versions of study NCT01382173 on Archive Site
Radiographic osteoarthritis [ Time Frame: 5 yrs ]
Same as current
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Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development
The Acute Knee Injury Project
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.
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Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Joint fluid, Serum & Plasma
Probability Sample

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.
  • Knee Injury
  • Knee Osteoarthritis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2019
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 40 Years   (Child, Adult)
Contact: Richard B Frobell, PhD +46424061027
Contact: Ola A Olsson, MD, PhD +46424063535
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Richard B Frobell, Lund University
Lund University
  • The Swedish Research Council
  • Crafoord Foundation
Not Provided
Lund University
September 2015