OsteoarthritisKORNNCT06451510
Knee Osteoarthritis in the Region of Norrbotten
An observational study of Osteoarthritis and Knee Injuries, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee Injuries, Knee Osteoarthritis
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 31 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sunderby Central Hospital of Norrbotten
Luleå, Norrbotten County, 971 80
Przemyslaw T Paradowski, MD, PhD, +46 708329574, przemyslaw.paradowski@umu.se
About this study
Official 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.
Read the detailed description
- 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.
- All patients are evaluated radiographically.
- 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.
- All patients are examined clinically.
- 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.
- The data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used in order to follow the long-term results.
- Conditions
- Osteoarthritis, Knee Injuries, Knee Osteoarthritis, Tibial Plateau Fractures, Tibial Fractures, Patient Satisfaction
- Keywords
- Osteoarthritis, Knee, Tibial plateau fracture, Outcome, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee Injuries, Osteoarthritis, Knee, Tibial Plateau Fractures, Tibial Fractures, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 5 years
Secondary outcomes (3)
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).
Measured: At least 5 years
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.
Measured: At least 5 years
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.
Measured: At least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Norrbotten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451510
- Sponsor's protocol ID
- DNR: 2016/20-31
- Other IDs
- SAR, SFR
- Acronym
- KORN
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40426131
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Osteoarthritis in the Region of Norrbotten (KORN)
- ClinicalTrials.gov ID
- NCT06451510
- Acronym / sponsor ID
- KORN / DNR: 2016/20-31
- Conditions
- Osteoarthritis, Knee Injuries, Knee Osteoarthritis, Tibial Plateau Fractures, Tibial Fractures, Patient Satisfaction
- Keywords
- Osteoarthritis, Knee, Tibial plateau fracture, Outcome, Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Norrbotten
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- All patients are evaluated radiographically.
- 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.
- All patients are examined clinically.
- 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.
- The data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used in order to follow the long-term results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with radiographic osteoarthritis (OA)
Time frame: At least 5 years
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 40426131Klaser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Knee Injuries, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Przemyslaw T Paradowski, MD, PhD (-46 708329574, przemyslaw.paradowski@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with radiographic osteoarthritis (OA) (time frame: At least 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.