Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures (POSITIF)

August 21, 2024 updated by: Juha Paloneva, Central Finland Hospital District

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Recruiting
        • Central Finland Hospital
        • Contact:
          • Juha Paloneva, MD, PhD
          • Phone Number: +358 14 2693119
        • Contact:
          • Valtteri Tapper, MD
        • Sub-Investigator:
          • Alar Toom, MD, PhD
        • Sub-Investigator:
          • Valtteri Tapper, MD, PhD
        • Principal Investigator:
          • Juha Paloneva, MD, PhD
        • Sub-Investigator:
          • Heikki Nurmi, MD, PhD
        • Sub-Investigator:
          • Maija Pesola, MD, PhD
        • Sub-Investigator:
          • Konsta Pamilo, MD, PhD
      • Kuopio, Finland
        • Not yet recruiting
        • Kuopio University Hospital
        • Contact:
          • Jussi Jalkanen, MD
        • Principal Investigator:
          • Jussi Jalkanen, MD, PhD
        • Sub-Investigator:
          • Tommi Kääriäinen, MD, PhD
      • Lahti, Finland
        • Not yet recruiting
        • Päijät-Häme Central Hospital
        • Contact:
          • Jussi Haapala, MD, PhD
        • Principal Investigator:
          • Jussi Haapala, MD, PhD
        • Sub-Investigator:
          • Sami Nurmi, MD
      • Oulu, Finland
        • Not yet recruiting
        • Oulu University Hospital
        • Contact:
          • Tuukka Niinimäki, MD, PhD
        • Principal Investigator:
          • Tuukka Niinimäki, MD, PhD
        • Sub-Investigator:
          • Tero Kortekangas, MD, PhD
      • Seinäjoki, Finland
        • Not yet recruiting
        • Seinäjoki Central Hospital
        • Contact:
          • Janne Jousmäki, MD, PhD
        • Principal Investigator:
          • Janne Jousmäki, MD, PhD
        • Sub-Investigator:
          • Ville Sumuvuori, MD, PhD
      • Tampere, Finland
        • Not yet recruiting
        • Tampere University Hospital
        • Contact:
          • Minna Laitinen, MD, PhD
        • Principal Investigator:
          • Ilari Pajamäki, MD
      • Tampere, Finland
        • Not yet recruiting
        • Coxa Joint Replacement Hospital
        • Contact:
          • Jyrki Nieminen, MD
        • Principal Investigator:
          • Jyrki Nieminen, MD, PhD
      • Turku, Finland
        • Not yet recruiting
        • Turku University Hospital
        • Contact:
          • Niko Strandberg, MD, PhD
        • Principal Investigator:
          • Niko Strandberg, MD, PhD
        • Sub-Investigator:
          • Mika Junnila, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ORIF (open reduction-internal fixation)

Osteosynthesis with locking plate(s) will be performed using medial and/or lateral incision, according to morphology of the fracture. Additional osteosynthesis material will be used when necessary. The articular surface will be reduced and bone transplantation or bone substitute used if required.

Postoperatively, touch-down weight bearing will be allowed for 6 weeks, followed by 2 weeks of half-weight-bearing period. A walker or wheelchair will be used when necessary.
Procedure: Locking plate
Osteosynthesis
Experimental: TKR (total knee replacement)
Arthroplasty of the knee will be performed within two weeks after the fracture. Medial parapatellar approach will be used. The minimal possible constraint of the prosthesis (cruciate retaining, posterior cruciate sacrificing or semi-constrained) will be used. A possible insufficient bone stock may be rebuilt with augments. Hinged prosthesis will be used only if stability of the medial collateral ligament is insufficient. A cemented or uncemented tibial stem extender (minimum length 50mm) will be used in all cases. Additional osteosynthesis will be used when necessary. Postoperatively, the patients will be allowed full weight bearing as tolerated.
Procedure: TKR
Total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee function
Time Frame: 12 months
Oxford knee score 12 months after randomisation
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
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)
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
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)
6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
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)
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Reoperations
Time Frame: Up to 10 years following randomisation
Need for revision surgery
Up to 10 years following randomisation
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)
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Complications
Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Any complication following injury or treatment
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
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)
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
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
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Finland Hospital District

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Oulu University Hospital
Kuopio University Hospital
Seinajoki Central Hospital
Tampere University Hospital
Coxa, Hospital for Joint Replacement
Paijat-Hame Hospital District

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juha Paloneva, MD, PhD, Central Finland Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnro 6U/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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