Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Lund University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Swedish Research Council
Crafoord Foundation
Information provided by (Responsible Party):
Richard B Frobell, Lund University
ClinicalTrials.gov Identifier:
NCT01382173
First received: June 23, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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
Traumatic 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 Lund University:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic osteoarthritis [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Joint fluid, Serum & Plasma


Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
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.
Criteria

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 ClinicalTrials.gov identifier: NCT01382173

Contacts
Contact: Richard B Frobell, PhD +46424061027 richard.frobell@med.lu.se
Contact: Ola A Olsson, MD, PhD +46424063535 ola.a.olsson@skane.se

Locations
Sweden
Department of Orthopedics, Helsingborg hospital Recruiting
Helsingborg, Sweden, S-251 85
Contact: Kerstin Akesson    +46424062032    kerstin.akesson@skane.se   
Principal Investigator: Richard B Frobell, PhD         
Sponsors and Collaborators
Lund University
The Swedish Research Council
Crafoord Foundation
  More Information

No publications provided

Responsible Party: Richard B Frobell, Associate Professor, Lund University
ClinicalTrials.gov Identifier: NCT01382173     History of Changes
Other Study ID Numbers: MOHAK-11
Study First Received: June 23, 2011
Last Updated: March 16, 2012
Health Authority: Sweden: Institutional Review Board

Keywords provided by Lund University:
Knee injury
Osteoarthritis
Anterior Cruciate Ligament injury
Patellar dislocation

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

ClinicalTrials.gov processed this record on October 22, 2014