Menu
Recruiting NCT06451510

Knee Osteoarthritis in the Region of Norrbotten

Observational Osteoarthritis Knee Injuries Knee Osteoarthritis Tibial Plateau Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee Injuries, Knee Osteoarthritis, Tibial Plateau Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Knee Osteoarthritis in the Region of Norrbotten (KORN)

Overview

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.

Primary outcome measures

  • Number of participants with radiographic osteoarthritis (OA) [Time frame: At least 5 years]
Secondary outcome measures (3)
  • Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint [Time frame: At least 5 years]
  • Score values in assessment of condition-specific health-related quality of life [Time frame: At least 5 years]
  • Score values in assessment of general health-related qualilty of life [Time frame: At least 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Sunderby Central Hospital of Norrbotten — Luleå

Publications

  • 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 40426131

Identifiers

NCT: NCT06451510 · DNR: 2016/20-31 · SAR · SFR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗