NCT06451510

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2020Dec 2027

Study Start

First participant enrolled

September 1, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

7.3 years

First QC Date

June 4, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

OsteoarthritisKneeTibial plateau fractureOutcomeArthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    At least 5 years

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

    At least 5 years

  • Score values in assessment of general health-related qualilty of life

    At least 5 years

Other Outcomes (1)

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

    At least 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunderby Central Hospital of Norrbotten

Luleå, Norrbotten County, 971 80, Sweden

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OsteoarthritisKnee InjuriesOsteoarthritis, KneeTibial Plateau FracturesTibial FracturesPatient Satisfaction

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and InjuriesKnee FracturesFractures, BoneTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Przemyslaw T Paradowski, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 11, 2024

Study Start

September 1, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations