Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03172715

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Hospital, Jyväskylä, Finland

Loading trial locations.

About this study

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 reduction- internal 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locking plate

Procedure

Osteosynthesis

TKR

Procedure

Total knee arthroplasty

Primary outcomes

  1. Knee function

    Time frame: 12 months

    Oxford knee score 12 months after randomisation

Secondary outcomes

  1. Change in knee function

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Change in Oxford knee score

  2. Change in pain

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Numeric rating scale (rest, night, exercise)

  3. Change in physical performance

    Time frame: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Short Physical Performance Battery (SPPB)

  4. Change in quality of life

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Short form-36 (SF-36)

  5. Reoperations

    Time frame: Up to 10 years following randomisation

    Need for revision surgery

  6. Satisfaction

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Satisfaction with knee (Numeric rating scale, range 0 to 10)

Other outcomes

  1. Pain medication

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Pain medication used (pills per day)

  2. Complications

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Any complication following injury or treatment

  3. Medical and social services (quantity)

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Use of medical and social services (quantity)

  4. Medical and social services (costs)

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

    Costs of medical and social services used

Study contacts

Contact information is provided by the study sponsor or research team.

Juha Paloneva, MD, PhD

CONTACT

[email protected]

+358 14 2693119

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Collaborators

  • Coxa, Hospital for Joint Replacement
  • Kuopio University Hospital
  • Oulu University Hospital
  • Paijat-Hame Hospital District
  • Seinajoki Central Hospital
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Official study title

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

Acronym: POSITIF

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Jun 1, 2017
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.