About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015
Disqualifiers
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
Trial 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).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint
The 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 life
The 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 life
Assessment 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 outcomes
Number of participants who had a surgical intervention due to OA secondary to the tibial plateau fracture
Number of participants who developed an end-stage OA and underwent either knee arthroplasty (either partial or total) or knee osteotomy.
Sponsors and contacts
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Umeå University
Lead sponsor
Region Norrbotten
Collaborator