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Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures (POSITIF)

Primary Purpose

Tibial Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Locking plate
TKR
Sponsored by
Central Finland Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Finland HospitalRecruiting
  • Kuopio University Hospital
  • Päijät-Häme Central Hospital
  • Oulu University Hospital
  • Seinäjoki Central Hospital
  • Coxa Joint Replacement Hospital
  • Tampere University Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ORIF (open reduction-internal fixation)

TKR (total knee replacement)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knee function
Oxford knee score 12 months after randomisation

Secondary Outcome Measures

Change in knee function
Change in Oxford knee score
Change in pain
Numeric rating scale (rest, night, exercise)
Change in physical performance
Short Physical Performance Battery (SPPB)
Change in quality of life
Short form-36 (SF-36)
Reoperations
Need for revision surgery
Satisfaction
Satisfaction with knee (Numeric rating scale, range 0 to 10)

Full Information

First Posted
May 22, 2017
Last Updated
February 7, 2023
Sponsor
Central Finland Hospital District
Collaborators
Tampere University Hospital, Coxa, Hospital for Joint Replacement, Oulu University Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital, Paijat-Hame Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT03172715
Brief Title
Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
Acronym
POSITIF
Official Title
Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Finland Hospital District
Collaborators
Tampere University Hospital, Coxa, Hospital for Joint Replacement, Oulu University Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital, Paijat-Hame Hospital District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ORIF (open reduction-internal fixation)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TKR (total knee replacement)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Locking plate
Intervention Description
Osteosynthesis
Intervention Type
Procedure
Intervention Name(s)
TKR
Intervention Description
Total knee arthroplasty
Primary Outcome Measure Information:
Title
Knee function
Description
Oxford knee score 12 months after randomisation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in knee function
Description
Change in Oxford knee score
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Change in pain
Description
Numeric rating scale (rest, night, exercise)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Change in physical performance
Description
Short Physical Performance Battery (SPPB)
Time Frame
6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Change in quality of life
Description
Short form-36 (SF-36)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Reoperations
Description
Need for revision surgery
Time Frame
Up to 10 years following randomisation
Title
Satisfaction
Description
Satisfaction with knee (Numeric rating scale, range 0 to 10)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Other Pre-specified Outcome Measures:
Title
Pain medication
Description
Pain medication used (pills per day)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Complications
Description
Any complication following injury or treatment
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Medical and social services (quantity)
Description
Use of medical and social services (quantity)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Title
Medical and social services (costs)
Description
Costs of medical and social services used
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juha Paloneva, MD, PhD
Phone
+358 14 2693119
Email
juha.paloneva@ksshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Organizational Affiliation
Central Finland Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Hospital
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Phone
+358 14 2693119
First Name & Middle Initial & Last Name & Degree
Valtteri Tapper, MD
First Name & Middle Initial & Last Name & Degree
Alar Toom, MD, PhD
First Name & Middle Initial & Last Name & Degree
Valtteri Tapper, MD, PhD
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Heikki Nurmi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Maija Pesola, MD, PhD
First Name & Middle Initial & Last Name & Degree
Konsta Pamilo, MD, PhD
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi Jalkanen, MD
First Name & Middle Initial & Last Name & Degree
Jussi Jalkanen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tommi Kääriäinen, MD, PhD
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi Haapala, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jussi Haapala, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sami Nurmi, MD
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuukka Niinimäki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tuukka Niinimäki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tero Kortekangas, MD, PhD
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janne Jousmäki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Janne Jousmäki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ville Sumuvuori, MD, PhD
Facility Name
Coxa Joint Replacement Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyrki Nieminen, MD
First Name & Middle Initial & Last Name & Degree
Jyrki Nieminen, MD, PhD
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minna Laitinen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ilari Pajamäki, MD
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niko Strandberg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Niko Strandberg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mika Junnila, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26264176
Citation
Houdek MT, Watts CD, Shannon SF, Wagner ER, Sems SA, Sierra RJ. Posttraumatic Total Knee Arthroplasty Continues to Have Worse Outcome Than Total Knee Arthroplasty for Osteoarthritis. J Arthroplasty. 2016 Jan;31(1):118-23. doi: 10.1016/j.arth.2015.07.022. Epub 2015 Jul 17.
Results Reference
background
PubMed Identifier
24430414
Citation
Wasserstein D, Henry P, Paterson JM, Kreder HJ, Jenkinson R. Risk of total knee arthroplasty after operatively treated tibial plateau fracture: a matched-population-based cohort study. J Bone Joint Surg Am. 2014 Jan 15;96(2):144-50. doi: 10.2106/JBJS.L.01691.
Results Reference
background
PubMed Identifier
24694275
Citation
Somersalo A, Paloneva J, Kautiainen H, Lonnroos E, Heinanen M, Kiviranta I. Incidence of fractures requiring inpatient care. Acta Orthop. 2014 Sep;85(5):525-30. doi: 10.3109/17453674.2014.908340. Epub 2014 Apr 3.
Results Reference
background
PubMed Identifier
21763651
Citation
Malviya A, Reed MR, Partington PF. Acute primary total knee arthroplasty for peri-articular knee fractures in patients over 65 years of age. Injury. 2011 Nov;42(11):1368-71. doi: 10.1016/j.injury.2011.06.198. Epub 2011 Jul 18.
Results Reference
background
PubMed Identifier
23771128
Citation
Kini SG, Sathappan SS. Role of navigated total knee arthroplasty for acute tibial fractures in the elderly. Arch Orthop Trauma Surg. 2013 Aug;133(8):1149-54. doi: 10.1007/s00402-013-1792-8. Epub 2013 Jun 16.
Results Reference
background
PubMed Identifier
26671570
Citation
Shimizu T, Sawaguchi T, Sakagoshi D, Goshima K, Shigemoto K, Hatsuchi Y. Geriatric tibial plateau fractures: Clinical features and surgical outcomes. J Orthop Sci. 2016 Jan;21(1):68-73. doi: 10.1016/j.jos.2015.09.008. Epub 2015 Dec 6.
Results Reference
background
PubMed Identifier
26885510
Citation
Haufe T, Forch S, Muller P, Plath J, Mayr E. The Role of a Primary Arthroplasty in the Treatment of Proximal Tibia Fractures in Orthogeriatric Patients. Biomed Res Int. 2016;2016:6047876. doi: 10.1155/2016/6047876. Epub 2016 Jan 18.
Results Reference
background

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Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

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