Knee Osteoarthritis in the Region of Norrbotten

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
At least 5 years

Secondary outcomes

1

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).

Time frame
At least 5 years
2

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.

Time frame
At least 5 years
3

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.

Time frame
At least 5 years

Other outcomes

1

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.

Time frame
At least 5 years

Sponsors and contacts

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Umeå University

Lead sponsor

Region Norrbotten

Collaborator