Comparing two treatments for knee fractures in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of two treatment options for intra-articular proximal tibia fractures in patients over 65 years old: open reduction and internal fixation (ORIF) using a locking plate versus primary total knee replacement (TKR). The focus is on assessing knee function and pain levels one year after treatment. Given the high failure rates and complications associated with ORIF in elderly patients, this study seeks to determine if TKR could provide better outcomes. Participants will be randomly assigned to one of the two treatment groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Central Finland Hospital
  Jyväskylä, Finland Recruiting
• Kuopio University Hospital
  Kuopio, Finland Not yet recruiting
• Päijät-Häme Central Hospital
  Lahti, Finland Not yet recruiting
• Oulu University Hospital
  Oulu, Finland Not yet recruiting
• Seinäjoki Central Hospital
  Seinäjoki, Finland Not yet recruiting
• Coxa Joint Replacement Hospital
  Tampere, Finland Not yet recruiting

Study contacts

• Principal investigator: Juha Paloneva, MD, PhD — Central Finland Hospital
• Study coordinator: Juha Paloneva, MD, PhD
• Email: juha.paloneva@ksshp.fi
• Phone: +358 14 2693119

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Robot-assisted closed reduction and internal fixation for distal tibial fractures

  This study tests whether an intelligent robot system can improve alignment and safety for patients with extra-articular distal tibia fractures compared with the usual surgeon-led reduction.

  Recruiting at 2 sites Beijing Jishuitan Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07733271

• Smart Crutch Tips to guide weight-bearing after tibial shaft fracture surgery

  This trial will test whether personalized, CT- and computer-model-based weight-bearing plans delivered through Smart Crutch Tips™ help adults recovering from surgically fixed tibial shaft fractures heal faster and return to full walking sooner.

  Recruiting at 16 sites Comeback Mobility Inc · Kyiv, Kyiv Oblast and 17 other locations · NCT07092579

• Comparing two types of intramedullary nails for healing tibial fractures

  This study is testing whether a new type of tibial nail helps people with stable tibial fractures heal better and recover faster than the standard nail.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06679049

• Blood flow restriction–enhanced rehabilitation for people with tibial shaft fractures.

  This trial will test whether using a blood flow restriction device during low-load strengthening exercises helps adults with tibial shaft fractures regain muscle strength and size, heal their fracture, and return to normal function faster than standard exercises alone.

  Recruiting Denver Health and Hospital Authority · Denver, Colorado · NCT06496035

• Assessing knee osteoarthritis in patients with tibial plateau fractures in Norrbotten

  This study looks at how common knee osteoarthritis is in people from Norrbotten, Sweden who had tibial plateau fractures, and it also checks how different factors might affect their recovery.

  Recruiting Umeå University · Luleå, Norrbotten County · NCT06451510

• Tissue ultrafiltration to prevent acute compartment syndrome after severe tibia fractures

  This trial tests whether placing tissue ultrafiltration (TUF) catheters in adults 18–60 with severe proximal tibia or tibial shaft fractures can lower muscle pressure and prevent acute compartment syndrome compared with standard care.

  Recruiting at 4 sites Major Extremity Trauma Research Consortium · Baltimore, Maryland and 3 other locations · NCT05889559

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.