Monitoring of Acute Knee Injuries to Understand Osteoarthritis Development
This study is currently recruiting participants.
Verified March 2012 by Lund University
Sponsor:
Lund University
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
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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:
- 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.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
- Pregnancy
- 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.
Contacts and Locations
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 Leg Injuries Wounds and Injuries |
Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013