Fracture severity and biomarker levels in synovial fluid as risk factors for the development of post-traumatic osteoarthritis in tibial plafond fractures

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030291

Enrollment

Registered

2022-09-14

Start date

2022-11-21

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S82.3 M19.1

Interventions

Group 1: Patients with acute tibial plafond fracture will be included in the study. Clinical CT images taken for planning fracture stabilization will be analyzed for the study to determine the severit

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: - Age: 18 to 60 years - Isolated, acute, closed or open AO/OTA 43-B or 43-C fracture as mono-injury - Patient is able to understand the study procedure and has given written informed consent.

Exclusion criteria

Exclusion criteria: - Pregnancy - Missing or incomplete clinical CT images - Injury to the lower ankle joint - Inflammatory arthritis or preexisting osteoarthritis in the injured ankle (previous diagnosis, obvious history, radiographic findings) - Other disease of the injured ankle (acute or past) - Regular use of non-steroidal or anti-inflammatory drugs - Cortisone injection in the injured ankle within 3 months prior to trauma - Autoimmune disease - Immune suppression

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the association between CT-based fracture severity and inflammatory/chondrodegenerative biomarker concentrations (interleukins, MMPs) in synovial fluid acutely after trauma in patients with tibial plafond fracture. And the predictive value of biomarker concentrations in synovial fluid and fracture severity regarding the development of PTOA within two years after trauma. Fracture severity analysis is performed by evaluating clinical CT scans for planning fracture stabilization and results in a quantitative severity score with three components: Fracture energy, fragment dispersion, and articular comminution. The synovial fluid obtained is analyzed by enzyme-linked immunosorbent assay (ELISA) after completion of recruitment to determine biomarker concentrations. Two years after trauma, PTOA outcome will be assessed radiographically using the Kellgren-Lawrence radiographic osteoarthritis score and functionally using the Ankle Osteoarthritis Scale, a patient questionnaire. Statistic analyses will be performed to determine the relationship between biomarker concentrations and fracture severity scores and to analyze the potential using the studied parameters to predict the risk of developing PTOA. For this purpose, patients will be assigned to either the PTOA or non-PTOA group based on their PTOA outcome.	—

Measure

Time frame

The primary endpoint is the association between CT-based fracture severity and inflammatory/chondrodegenerative biomarker concentrations (interleukins, MMPs) in synovial fluid acutely after trauma in patients with tibial plafond fracture. And the predictive value of biomarker concentrations in synovial fluid and fracture severity regarding the development of PTOA within two years after trauma. Fracture severity analysis is performed by evaluating clinical CT scans for planning fracture stabilization and results in a quantitative severity score with three components: Fracture energy, fragment dispersion, and articular comminution. The synovial fluid obtained is analyzed by enzyme-linked immunosorbent assay (ELISA) after completion of recruitment to determine biomarker concentrations. Two years after trauma, PTOA outcome will be assessed radiographically using the Kellgren-Lawrence radiographic osteoarthritis score and functionally using the Ankle Osteoarthritis Scale, a patient questionnaire. Statistic analyses will be performed to determine the relationship between biomarker concentrations and fracture severity scores and to analyze the potential using the studied parameters to predict the risk of developing PTOA. For this purpose, patients will be assigned to either the PTOA or non-PTOA group based on their PTOA outcome.

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Secondary

Measure	Time frame
PTOA outcome in patients with tibia plafond fractures two years after trauma	—

Countries

Germany

Contacts

Public ContactKatharina Trenkwalder

BG Unfallklinik Murnau Institut für Biomechanik

katharina.trenkwalder@bgu-murnau.de08841/48 3059

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026