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Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures

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ClinicalTrials.gov Identifier: NCT03769909
Recruitment Status : Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
University of Freiburg
Odense University Hospital
The Danish Rheumatism Association
Hartmanns Fond
AP Møller Fond
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

Intra-articular fracture is a very common fracture. The only method to treat these fractures is surgery with plate and screws followed by rehabilitation. Even though the surgeons do their best to restore the anatomy, up to 40 percent of the patients develop osteoarthritis after 10 years. Previous research has shown that immediately after fracture in the joint, the body starts an inflammatory response and activates a series of biomarkers inside the joint space. Some of these biomarkers are believed to break down the cartilage resulting in development of osteoarthritis, despite surgical treatment. Currently it is still unknown, which biomarkers are activated in the joint space, and how we can stop their deleterious action in order to prevent cartilage degradation.

The purpose of this project is to identify the biomarkers in the joint space after an intra-articular ankle fracture and to evaluate how these biomarkers affect the short- and mid-terms clinical outcomes. As secondary outcomes we evaluate how fracture classification and fracture reduction affect clinical outcomes and physical activity after surgery.


Condition or disease
Ankle Fractures Intra-Articular Fractures Osteoarthritis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inhibition of Inflammation for Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

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Primary Outcome Measures :
  1. Concentration of cytokines in fracture ankle versus non-fracture ankle [ Time Frame: During surgery ]
    Multiplex ELISA kits will be use to identify cytokines in both ankles. Cytokines with significant difference will be identified.

  2. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (AOFAS) [ Time Frame: 12 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of functional foot score (AOFAS), The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points


Secondary Outcome Measures :
  1. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (FFI.DK) [ Time Frame: 12 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of FFI.DK, a functional foot score

  2. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (EQ5D-5L) [ Time Frame: 12 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of EQ5D-5L

  3. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (VAS-score) [ Time Frame: 12 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to VAS-score, a Visual Analog Scale.VAS 0 (best) - 10 (worst)

  4. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (Swelling) [ Time Frame: 12 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to swelling, difference in fracture and non-fracture ankle, measured in millimeters

  5. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (FFI.DK) [ Time Frame: 3 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of FFI.DK, a functional foot score

  6. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (EQ5D-5L) [ Time Frame: 3 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of EQ5D-5L

  7. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (VAS-score) [ Time Frame: 3 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of VAS-score, a Visual Analog Scale.VAS 0 (best) - 10 (worst)

  8. Cytokines (identified in primary outcome 1) correlation with clinical outcomes (Swelling) [ Time Frame: 3 months after surgery ]
    The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to swelling, difference in fracture and non-fracture ankle, measured in millimeters


Other Outcome Measures:
  1. Correlation between fracture classification and clinical outcomes (AOFAS) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to the scores of functional foot score (AOFAS), The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points

  2. Correlation between fracture classification and clinical outcomes (FFI.DK) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to the scores of functional foot score (FFI.DK)

  3. Correlation between fracture classification and clinical outcomes (EQ5D-5L) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to the scores of EQ5D-5L

  4. Correlation between fracture classification and clinical outcomes (VAS-score) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to the scores of VAS-score, a Visual Analog Scale.VAS 0 (best) - 10 (worst)

  5. Correlation between fracture classification and clinical outcomes (Swelling) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to swelling, difference in fracture and non-fracture ankle, measured in millimeters

  6. Correlation between fracture classification and clinical outcomes (activity) [ Time Frame: 12 months after surgery ]
    Fracture classification on pre-operative X-ray (AO classification, 43A, 43B, 43C, 44A, 44B,44C), will be correlated to activity, meassured with an activity tracker, recording number of active minutes per day

  7. Correlation between fracture reduction and clinical outcomes (AOFAS) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to the scores of functional foot score (AOFAS), The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points

  8. Correlation between fracture reduction and clinical outcomes (FFI.DK) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to the scores of functional foot score (FFI.DK)

  9. Correlation between fracture reduction and clinical outcomes (EQ5D-5L) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to the scores of EQ5D-5L

  10. Correlation between fracture reduction and clinical outcomes (VAS-score) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to the scores of VAS-score, a Visual Analog Scale.VAS 0 (best) - 10 (worst)

  11. Correlation between fracture reduction and clinical outcomes (Swelling) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to swelling, difference in fracture and non-fracture ankle, measured in millimeters

  12. Correlation between fracture reduction and clinical outcomes (activity) [ Time Frame: 12 months after surgery ]
    Fracture reduction with conventional X-ray and 3D-rotation CT (e.g. step-off>2 mm, tibiotalartilt >2° and deviation of rotation > 6°) will be correlated to activity, meassured with an activity tracker, recording number of active minutes per day


Biospecimen Retention:   Samples With DNA
Whole blood (5.0-20.0 ml) Synovial Fluids (1.0-10.0 ml) from both ankle joints


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients hospitalize in Odense University, Svendborg (31th. Oct. 2017-Jan. 2019) will be screened for eligibility.
Criteria

Inclusion Criteria:

  • Age between 18 and 65 years
  • Existence of an acute fracture involving the ankle (location AO43,AO44) requiring open or closed reduction and internal or external fixation within 14 days
  • Being able to read and understand Danish
  • Informed consent

Exclusion Criteria:

  • Open fractures
  • Associated arterial and nerve injuries
  • Multiple injured patients with an Injury Severity Score >16
  • Primary or secondary infections
  • Injuries associated to a Charcot foot
  • Signs of existing OA on X-ray

    • Others

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769909


Locations
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Denmark
The Orthopaedic Research Unit
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
University of Freiburg
Odense University Hospital
The Danish Rheumatism Association
Hartmanns Fond
AP Møller Fond
Investigators
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Principal Investigator: Søren Overgaard, Professor The Orthopaedic Research Unit

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03769909     History of Changes
Other Study ID Numbers: S-20170139
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southern Denmark:
PTOA
Osteoarthritis
Intra-Articular Fractures
Ankle Fractures
Cytokines
Biomarkers
Inflammation
Pro-inflammatory
Cartilage
Fracture
Joint Injury

Additional relevant MeSH terms:
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Osteoarthritis
Fractures, Bone
Ankle Fractures
Intra-Articular Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries