Knee Osteoarthritis in the Region of Norrbotten

NCT ID: NCT06451510

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

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1. 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.
2. All patients are evaluated radiographically.
3. 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.
4. All patients are examined clinically.
5. 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.
6. The data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used in order to follow the long-term results.

Conditions

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Osteoarthritis Knee Injuries Knee Osteoarthritis Tibial Plateau Fractures Tibial Fractures Patient Satisfaction Quality of Life Complication of Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Norrbotten

UNKNOWN

Sponsor Role collaborator

UmeƄ University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunderby Central Hospital of Norrbotten

LuleƄ, Norrbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Przemyslaw T Paradowski, MD, PhD

Role: CONTACT

-46 708329574

Facility Contacts

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Przemyslaw T Paradowski, MD, PhD

Role: primary

+46 708329574

References

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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.

Reference Type DERIVED
PMID: 40426131 (View on PubMed)

Other Identifiers

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SAR

Identifier Type: REGISTRY

Identifier Source: secondary_id

SFR

Identifier Type: REGISTRY

Identifier Source: secondary_id

DNR: 2016/20-31

Identifier Type: -

Identifier Source: org_study_id

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