Clinical trial NCT03172715: Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures
Official title: Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tibial Fractures
Keywords: Open reduction internal fixation
Arthroplasty
Surgery
Randomized controlled trial
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Coxa, Hospital for Joint Replacement
name: Oulu University Hospital
name: Turku University Hospital
name: Kuopio University Hospital
name: Seinajoki Central Hospital
name: Paijat-Hame Hospital District
First posted: 2017-06-01
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee function
timeFrame: 12 months
Secondary outcomes:
measure: Change in knee function
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Change in pain
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Change in physical performance
timeFrame: 6 weeks (TKR only), 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Change in quality of life
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Reoperations
timeFrame: Up to 10 years following randomisation
measure: Satisfaction
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Other outcomes:
measure: Pain medication
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Complications
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Medical and social services (quantity)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
measure: Medical and social services (costs)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 5 years, 10 years
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Coxa Joint Replacement Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Central Finland Hospital
name: Juha Paloneva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.