Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures (POSITIF)

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: Recruiting
• Conditions: Tibial Fractures
• Intervention / Treatment: Procedure: Locking plate; Procedure: TKR

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: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juha Paloneva, MD, PhD; Phone Number: +358 14 2693119; Email: juha.paloneva@ksshp.fi

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Knee function	Oxford knee score 12 months after randomisation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee function	Change in Oxford knee score	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Change in pain	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	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	Short form-36 (SF-36)	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Reoperations	Need for revision surgery	Up to 10 years following randomisation
Satisfaction	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

Outcome Measure	Measure Description	Time Frame
Pain medication	Pain medication used (pills per day)	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Complications	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)	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)	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

• Sponsor: Central Finland Hospital District
• Collaborators: 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: Principal Investigator: Juha Paloneva, MD, PhD, Central Finland Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Arthroplasty; Randomized controlled trial; Open reduction internal fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID 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