Clinical trial NCT06451510: Knee Osteoarthritis in the Region of Norrbotten
Official title: Knee Osteoarthritis in the Region of Norrbotten (KORN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Knee Injuries
Knee Osteoarthritis
Tibial Plateau Fractures
Tibial Fractures
Patient Satisfaction
Quality of Life
Complication of Treatment
Keywords: Osteoarthritis
Knee
Tibial plateau fracture
Outcome
Arthroplasty
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Norrbotten
First posted: 2024-06-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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

Primary outcomes:
measure: Number of participants with radiographic osteoarthritis (OA)
timeFrame: At least 5 years
Secondary outcomes:
measure: Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint
timeFrame: At least 5 years
measure: Score values in assessment of condition-specific health-related quality of life
timeFrame: At least 5 years
measure: Score values in assessment of general health-related qualilty of life
timeFrame: At least 5 years
Other outcomes:
measure: Number of participants who had a surgical intervention due to OA secondary to the tibial plateau fracture
timeFrame: At least 5 years
Locations:
city: Luleå
country: Sweden
facility: Sunderby Central Hospital of Norrbotten
state: Norrbotten
Study officials:
References: