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Knee Osteoarthritis in the Region of Norrbotten

Knee Osteoarthritis in the Region of Norrbotten (KORN)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06451510
Acronym
KORN
Enrollment
500
Registered
2024-06-11
Start date
2020-09-01
Completion date
2027-12-31
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Treatment, Knee Injuries, Knee Osteoarthritis, Osteoarthritis, Patient Satisfaction, Quality of Life, Tibial Fractures, Tibial Plateau Fractures

Keywords

Osteoarthritis, Knee, Tibial plateau fracture, Outcome, Arthroplasty

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.

Detailed description

1. The study population consists of patients from the Swedish region of Norrbotten (northern part of Sweden) who had undergone TPF between the years of 2001 and 2015. 2. All patients are evaluated radiographically. 3. Condition-specific scores are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). General health related quality of life are assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L) tool. 4. All patients are examined clinically. 5. The relationship between the development of radiographic OA in patients who had undergone TPF and such potential factors as gender, age, body mass index (BMI), fracture pattern or method of fracture treatment is being assessed. 6. The data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used in order to follow the long-term results.

Interventions

None listed

Sponsors

Region Norrbotten
CollaboratorUNKNOWN
Umeå University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with radiographic osteoarthritis (OA)At least 5 yearsNumber 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.

Secondary

MeasureTime frameDescription
Score values in the condition-specific measure for assessment of symptoms and function related to the knee jointAt least 5 yearsThe Knee injury and Osteoarthrtis Outcome Scale (KOOS) is used. KOOS is a self-administered knee-specific questionnaire consisting of 42 items in five subscales. A normalized score from 0 (extreme problems) to 100 (no problems at all) are calculated separately for each of the five subscales. Knee-related symptoms and function are evaluated with use of four out of five KOOS subscales: Pain, other Symptoms, Function in daily living (ADL) and Function in sport and recreation (Sport/Rec).
Score values in assessment of condition-specific health-related quality of lifeAt least 5 yearsThe condition-specific measure, Knee injury and Osteoarthrtis Outcome Scale (KOOS) is used. The score values in the KOOS subscale knee-related Quality of Life (QOL) are evaluated.
Score values in assessment of general health-related qualilty of lifeAt least 5 yearsAssessment is performed with the EuroQol 5-Dimension 5-level (EQ-5D-5L). The questionnaire consists of five questions exploring five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from no problems to extreme problems. An EQ-5D-5L index of 1.0 indicates the best possible health state and 0.0 denotes death.

Other

MeasureTime frameDescription
Number of participants who had a surgical intervention due to OA secondary to the tibial plateau fractureAt least 5 yearsNumber of participants who developed an end-stage OA and underwent either knee arthroplasty (either partial or total) or knee osteotomy.

Countries

Sweden

Contacts

Primary ContactPrzemyslaw T Paradowski, MD, PhD
przemyslaw.paradowski@umu.se-46 708329574

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026