RecruitingNot Applicable

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Finland98 participantsStarted 2018-01-09

Plain-language summary

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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Knee function

Timeframe: 12 months

Trial details

NCT IDNCT03172715

SponsorCentral Finland Hospital District

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Juha Paloneva, MD, PhD

+358 14 2693119 juha.paloneva@ksshp.fi

View on ClinicalTrials.gov More Tibial Fractures trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.