Prevalence of osteoarthritis and clinical outcomes in patients with fractures of the tibial plateau - medium- and long-term analysis.
Jon Klasér, Lisa Kotake, Marcus Lindberg...
https://pubmed.ncbi.nlm.nih.gov/40426131Actively Recruiting
Age: 18Years +
All Genders
ID06451510
Knee Osteoarthritis in the Region of Norrbotten (KORN)
Led by Umeå University · Updated on 2024-06-18
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Norrbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying knee osteoarthritis in patients from the Swedish region of Norrbotten who experienced tibial plateau fractures between 2001 and 2015. The study aims to find out how common radiographic knee osteoarthritis is after these fractures and to understand medium and long-term functional outcomes. It also looks for risk factors linked to these outcomes, including gender, age, body mass index, fracture pattern, and treatment method. Participants in this observational study undergo radiographic evaluations, clinical examinations, and assessments using the Knee injury and Osteoarthritis Outcome Score (KOOS). General health and quality of life are measured with the EuroQol 5-Dimension 5-level (EQ-5D-5L) tool. Data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used to follow long-term results and outcomes. During the study, participants will be monitored for at least five years after their injury to track the development of osteoarthritis through imaging and condition-specific scores. Researchers will assess symptoms, knee function, and health-related quality of life over time. The primary outcome is the number of participants showing radiographic osteoarthritis at five years or more. Secondary outcomes include symptom and function scores, condition-specific quality of life, and general health quality of life evaluations.
CONDITIONS
Brief Title
Knee Osteoarthritis in the Region of Norrbotten
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015
You will not qualify if you...
- Death without bilateral weighted X-ray minimum 5 years post injury
- Open growth plate in distal femur and/or proximal tibia
- Extraarticular or isolated eminentia fracture
- Osteoarthritis prior to injury
- Having a rheumatic disorder involving joints
- Earlier and/or later severe injury to the index knee
- Having cognitive disorders disqualifying from the study
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At least 5 years
Participants undergo radiographic evaluation and clinical examination to assess knee osteoarthritis and related health outcomes.
Periodic assessments over 5 years
Long-term Monitoring
Duration - At least 5 years
Participants are observed over time to evaluate the development of osteoarthritis and related clinical outcomes using registry data and clinical scores.
Data collection through registry follow-up and clinical assessments
Trial Site Locations
Total: 1 location
1
Sunderby Central Hospital of Norrbotten
Luleå, Norrbotten County, Sweden, 971 80
Actively Recruiting
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Research Team
P
Przemyslaw T Paradowski, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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