Actively Recruiting
Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
Led by Central Finland Hospital District · Updated on 2024-08-22
98
Participants Needed
8
Research Sites
594 weeks
Total Duration
On this page
Sponsors
C
Central Finland Hospital District
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.
CONDITIONS
Official Title
Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Central Finland Hospital
Jyväskylä, Finland, 40620
Actively Recruiting
2
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
3
Päijät-Häme Central Hospital
Lahti, Finland
Not Yet Recruiting
4
Oulu University Hospital
Oulu, Finland
Not Yet Recruiting
5
Seinäjoki Central Hospital
Seinäjoki, Finland
Not Yet Recruiting
6
Coxa Joint Replacement Hospital
Tampere, Finland
Not Yet Recruiting
7
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
8
Turku University Hospital
Turku, Finland
Not Yet Recruiting
Research Team
J
Juha Paloneva, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here