Knee Osteoarthritis in the Region of Norrbotten
KORN
3 other identifiers
observational
500
1 country
1
Brief Summary
The goal of this observational study is to assess the prevalence of radiographic knee osteoarthritis and to report medium and long term functional outcomes secondary to tibia plateau fractures. The second aim was to investigate whether there were any risk factors associated with these outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 4, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 18, 2024
June 1, 2024
7.3 years
June 4, 2024
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with radiographic osteoarthritis (OA)
Number of participants with radiographic OA at follow-up at least five years after the tibial plateau fracture was considered the primary endpoint of this study.
At least 5 years
Secondary Outcomes (3)
Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint
At least 5 years
Score values in assessment of condition-specific health-related quality of life
At least 5 years
Score values in assessment of general health-related qualilty of life
At least 5 years
Other Outcomes (1)
Number of participants who had a surgical intervention due to OA secondary to the tibial plateau fracture
At least 5 years
Eligibility Criteria
The study group consists the subjects who underwent tibial plateau fracture and that could be identified by a computer-assisted search of the local medical journal database Vård Administrativt System (VAS), using the ICD-10 diagnostic codes for proximal tibia fracture (open and closed) (S82.1, S82.8 and S 82.9).
You may qualify if:
- Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015
You may not qualify if:
- 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
- OA 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- Region Norrbottencollaborator
Study Sites (1)
Sunderby Central Hospital of Norrbotten
Luleå, Norrbotten County, 971 80, Sweden
Related Publications (1)
Klaser J, Kotake L, Lindberg M, Wigge S, Lundqvist R, Szczesny G, Paradowski PT. Prevalence of osteoarthritis and clinical outcomes in patients with fractures of the tibial plateau - medium- and long-term analysis. BMC Musculoskelet Disord. 2025 May 27;26(1):522. doi: 10.1186/s12891-025-08786-7.
PMID: 40426131DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2024
First Posted
June 11, 2024
Study Start
September 1, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 18, 2024
Record last verified: 2024-06