Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT03172715
• Date of registration: 22/05/2017
• Prospective Registration: Yes
• Primary sponsor: Central Finland Hospital District
• Public title: Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures POSITIF
• Scientific title: Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
• Date of first enrolment: January 9, 2018
• Target sample size: 98
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03172715
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Juha Paloneva, MD, PhD

• Name: Juha Paloneva, MD, PhD
• Affiliation: Central Finland Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Acute intra-articular proximal tibia fracture with impression of the joint cartilage
(Schatzker grades II to VI)

- Impression of tibial plateau min 2 mm

- Intact patellar tendon

- The patient accepts both treatment options (osteosynthesis and arthroplasty)

Exclusion Criteria:

- Not voluntary

- Previous arthroplasty of the knee

- Previous fracture affecting the knee joint

- Inability to co-operate

- Not independent (institutionalized living before fracture)

- Severe osteoarthritis (Kellgren-Lawrence grade 4)

- Open fracture (Gustilo grade 2 or over)

- Progressive metastatic malign disease

- Multiple fractures requiring operative treatment

- Severe soft tissue injury around the knee (Tscherne classification grade 3)

- Avulsion fracture of the patellar tendon or concomitant patellar tendon tear

- Inability to walk before fracture

- Severe medical comorbidities

- Body Mass Index over 40

- Unacceptably high risk of surgery due to severe medical comorbidities

- Significant arterial or nerve trauma

- Severe substance abuse



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tibial Fractures

Intervention(s)

Procedure: Locking plate

Procedure: TKR

Primary Outcome(s)

Knee function [Time Frame: 12 months]

Secondary Outcome(s)

Change in physical performance [Time Frame: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

Change in pain [Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

Reoperations [Time Frame: Up to 10 years following randomisation]

Change in knee function [Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

Change in quality of life [Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

Satisfaction [Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

Secondary ID(s)

Dnro 6U/2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Seinajoki Central Hospital

Tampere University Hospital

Oulu University Hospital

Paijat-Hame Hospital District

Turku University Hospital

Coxa, Hospital for Joint Replacement

Kuopio University Hospital