This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2015 by Richard B Frobell, Lund University
The Swedish Research Council
Crafoord Foundation
Information provided by (Responsible Party):
Richard B Frobell, Lund University Identifier:
First received: June 23, 2011
Last updated: September 10, 2015
Last verified: September 2015
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.

Knee Injury Knee Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Acute Knee Injury Project

Resource links provided by NLM:

Further study details as provided by Richard B Frobell, Lund University:

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

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

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

Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Richard B Frobell, Associate Professor, Lund University Identifier: NCT01382173     History of Changes
Other Study ID Numbers: MOHAK-11
Study First Received: June 23, 2011
Last Updated: September 10, 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 processed this record on September 21, 2017