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NCT Number: NCT06451510

Knee Osteoarthritis in the Region of Norrbotten

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.

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Key information

Conditions

Osteoarthritis Arthritis Behavior Complication of Treatment Fractures, Bone Health Behavior Joint Diseases Knee Fractures Knee Injuries Knee Osteoarthritis Leg Injuries Musculoskeletal Diseases Osteoarthritis, Knee Patient Satisfaction Quality of Life Rheumatic Diseases Tibial Fractures Tibial Plateau Fractures Treatment Adherence and Compliance Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunderby Central Hospital of Norrbotten

Luleå, Norrbotten County, 971 80, Sweden

Location status: Recruiting

Location contact

Przemyslaw T Paradowski, MD, PhD

CONTACT

[email protected]

+46 708329574

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint

    Time frame: At least 5 years

    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).

  2. Score values in assessment of condition-specific health-related quality of life

    Time frame: At least 5 years

    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.

  3. Score values in assessment of general health-related qualilty of life

    Time frame: At least 5 years

    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

  1. Number of participants who had a surgical intervention due to OA secondary to the tibial plateau fracture

    Time frame: At least 5 years

    Number of participants who developed an end-stage OA and underwent either knee arthroplasty (either partial or total) or knee osteotomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Przemyslaw T Paradowski, MD, PhD

CONTACT

[email protected]

-46 708329574

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Norrbotten

Registry information

Official study title

Knee Osteoarthritis in the Region of Norrbotten (KORN)

Acronym: KORN

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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