Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tibial Fractures

Intervention / Treatment
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* Procedure: Locking plate
* Procedure: TKR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ORIF (open reduction-internal fixation)<br>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<br>* Osteosynthesis<br>|
| Experimental: TKR (total knee replacement)<br>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<br>* Total knee arthroplasty<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open reduction internal fixation, Arthroplasty, Surgery, Randomized controlled trial