Comparing two treatments for knee fractures in older adults

Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial

This study is testing whether a total knee replacement works better than traditional surgery for knee fractures in people over 65 to see which option leads to less pain and better knee function after a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Central Finland Hospital District (other)
• Locations: 8 sites (Jyväskylä and 7 other locations)
• Trial ID: NCT03172715 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are elderly patients over 65 years old with acute intra-articular proximal tibia fractures that meet specific criteria.

Not a fit: Patients with severe medical comorbidities, previous knee arthroplasty, or those unable to cooperate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved knee function and reduced pain for elderly patients with proximal tibia fractures.

How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of TKR for similar conditions, making this approach both relevant and potentially novel.

Eligibility 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

Where this trial is running

Jyväskylä and 7 other locations

• 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)
• Tampere University Hospital — Tampere, Finland (NOT_YET_RECRUITING)
• Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Juha Paloneva, MD, PhD — Central Finland Hospital
• Study coordinator: Juha Paloneva, MD, PhD

Conditions: Tibial Fractures, Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial