Knee Osteoarthritis in the Region of Norrbotten

Quality of Life Clinical Trial

— KORN  

Official title:

Knee Osteoarthritis in the Region of Norrbotten (KORN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451510
• Other study ID #: DNR: 2016/20-31
• Secondary ID: SARSFR
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Umeå University
• Contact: Przemyslaw T Paradowski, MD, PhD
• Phone: -46 708329574
• Email: przemyslaw.paradowski[@]umu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Complication of Treatment
• Fractures, Bone
• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Patient Satisfaction
• Quality of Life
• Tibial Fractures

Locations

Country	Name	City	State
Sweden	Sunderby Central Hospital of Norrbotten	Luleå	Norrbotten

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Region Norrbotten

Country where clinical trial is conducted

Sweden, 

Outcome

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