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
The Swedish Research Council
Information provided by (Responsible Party):
Richard B Frobell, Lund University
First received: June 23, 2011
Last updated: March 16, 2012
Last verified: March 2012
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.
Traumatic Knee Injury
||Observational Model: Case-Only
Time Perspective: Prospective
||The Acute Knee Injury Project
Primary Outcome Measures:
- Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Radiographic osteoarthritis [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Joint fluid, Serum & Plasma
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||12 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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:
- Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital
- 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.
- Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
- A history of knee injury not more than 4 weeks prior to inclusion
- Agreement and informed consent to participate in the study
- Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
- A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
- General disease that effects physical function or systemic medication/abuse of steroids
- Any other condition or treatment interfering with the completion or assessment of the trial.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01382173
|Department of Orthopedics, Helsingborg hospital
|Helsingborg, Sweden, S-251 85 |
|Contact: Kerstin Akesson +46424062032 firstname.lastname@example.org |
|Principal Investigator: Richard B Frobell, PhD |
The Swedish Research Council
No publications provided
||Richard B Frobell, Associate Professor, Lund University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2011
||March 16, 2012
||Sweden: Institutional Review Board
Keywords provided by Lund University:
Anterior Cruciate Ligament injury
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Wounds and Injuries