Image

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Recruiting
65 years and older
All
Phase N/A

Powered by AI

Overview

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.

Description

Intra-articular proximal tibial fractures are relatively common in the elderly. They constitute 8% of all fractures in patients over 65 years. Open reduction and internal fixation (ORIF) is the golden standard treatment for these fractures.

The treatment with ORIF is associated with significant co-morbidity due to complicating concomitant factors, such as osteoporosis, poor co-operation, infection and inadequate stability of osteosynthesis. A high failure rate (30-79 %) of fixation of tibia plateau fractures in elderly people has been reported. Most of these fractures occur in elderly persons who are at risk to lose their ability to walk independently, because of partial immobilization is required initially and full weight bearing is not allowed during 6 to 8 weeks after the operation. The risk of post-traumatic osteoarthritis has been reported to be 5.3-times higher than in the normal population even if adequate stability is achieved and other conditions normalized for fracture healing. It has also been reported that total knee replacement (TKR) performed for post-traumatic arthritis after tibial plateau fracture lead to worse outcome compared with TKR due to primary osteoarthritis. In addition, previous operations increase the risk of complications after TKR. The complication rate in secondary TKR has been reported to be over 18 %.

The available data regarding TKR as a primary treatment option for proximal tibial plateau fracture suggest that fast mobilization and return to normal daily activities may be achieved. These data also suggest a low rate of complications. There are no randomized controlled trials comparing the outcomes of the traditional treatment option (open reductioninternal fixation, ORIF) and TKR as primary treatment of these fractures. In this study investigators compare the outcomes of locking plate osteosynthesis and total knee arthroplasty according to Oxford knee score, pain, ability to walk, or quality of life one year after randomization in 98 patients aged over 65 years.

Eligibility

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

Study details
    Tibial Fractures

NCT03172715

Central Finland Hospital District

21 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.