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Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development

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ClinicalTrials.gov Identifier: NCT01382173
Recruitment Status : Recruiting
First Posted : June 27, 2011
Last Update Posted : September 11, 2015
Sponsor:
Collaborators:
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 ClinicalTrials.gov Archive Site
Radiographic osteoarthritis [ Time Frame: 5 yrs ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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)
No
Contact: Richard B Frobell, PhD +46424061027 richard.frobell@med.lu.se
Contact: Ola A Olsson, MD, PhD +46424063535 ola.a.olsson@skane.se
Sweden
 
 
NCT01382173
MOHAK-11
No
Not Provided
Not Provided
Richard B Frobell, Lund University
Lund University
  • The Swedish Research Council
  • Crafoord Foundation
Not Provided
Lund University
September 2015