Quality of Life Clinical Trial
— KORNOfficial title:
Knee Osteoarthritis in the Region of Norrbotten (KORN)
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sunderby Central Hospital of Norrbotten | Luleå | Norrbotten |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Region Norrbotten |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | At least 5 years | |
Primary | 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. | At least 5 years | |
Secondary | 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). |
At least 5 years | |
Secondary | 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. | At least 5 years | |
Secondary | 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. | At least 5 years |
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