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Recruiting NCT03172715

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

No phase Interventional Tibial Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Locking plate, TKR.
Who it may be relevant to
Registry conditions: Tibial Fractures. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Locking plate
    Osteosynthesis
  • Procedure TKR
    Total knee arthroplasty

Primary outcome measures

  • Knee function [Time frame: 12 months]
Secondary outcome measures (6)
  • Change in knee function [Time frame: 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]
  • Change in physical performance [Time frame: 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]
  • Reoperations [Time frame: Up to 10 years following randomisation]
  • Satisfaction [Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 8 centers
  • Central Finland Hospital — Jyväskylä
  • Kuopio University Hospital — Kuopio
  • Päijät-Häme Central Hospital — Lahti
  • Oulu University Hospital — Oulu
  • Seinäjoki Central Hospital — Seinäjoki
  • Coxa Joint Replacement Hospital — Tampere
  • Tampere University Hospital — Tampere
  • Turku University Hospital — Turku

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. PMID 26264176
  • 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. PMID 24430414
  • 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. PMID 24694275
  • 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. PMID 21763651
  • 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. PMID 23771128
  • 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. PMID 26671570
  • 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. PMID 26885510

Identifiers

NCT: NCT03172715 · Dnro 6U/2017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗